ThermoCool SmartTouch D132701Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10846835009163), received between Sep 28, 2015 and Jun 27, 2024 — classified as 41 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (30 reports).

8 other recalls cover devices cleared under the same FDA submission (P030031, P040036); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHINODA Y, KOMATSU Y, HATTORI M, ODA Y, IIOKA Y, HANAKI Y, YAMASAKI H, IGARASHI M, ISHIZU T, NOGAMI A. OPTIMAL CARDIAC RHYTHM DURING SUBSTRATE MAPPING IN SCAR-RELATED VENTRICULAR TACHYCARDIA: SIGNIFICANCE OF WAVEFRONT DIRECTION ON IDENTIFYING CRITICAL SITES. HEART RHYTHM. 2024 MAR 1:S1547-5271(24)00232-7. DOI: (B)(4). EPUB AHEAD OF PRINT. PMID: 38432425. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: A ROTATIONAL ACTIVATION PATTERN (RAP) AROUND THE LOCALIZED LINE OF A CONDUCTION BLOCK OFTEN CORRELATES WITH SITES SPECIFIC TO THE CRITICAL ZONES OF VENTRICULAR TACHYCARDIA (VT). THE WAVEFRONT DIRECTION DURING SUBSTRATE MAPPING AFFECTS MANIFESTATION OF THE RAP AND LINE OF BLOCK. OBJECTIVE: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE MOST OPTIMAL CARDIAC RHYTHM FOR IDENTIFYING RAP AND LINE OF BLOCK IN SUBSTRATE MAPPING. METHODS: WE RETROSPECTIVELY EVALUATED 71 MAPS (MEDIAN 3205 POINTS/MAP) IN 46 PATIENTS (65 ± 15 YEARS; 33% WITH ISCHEMIC CARDIOMYOPATHY) WHO UNDERWENT HIGH-DENSITY SUBSTRATE MAPPING AND ABLATION OF SCAR-RELATED VT. APPEARANCE OF A RAP DURING SINUS, RIGHT VENTRICULAR (RV)-PACED, LEF

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 19625081 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OLGUN, F.E., KILICASLAN, F. (2023). RARE THROMBOEMBOLIC COMPLICATIONS OF CAVOTRICUSPID ISTHMUS ABLATION: SINGLE CENTER EXPERIENCE. E JOURNAL OF CARDIOVASCULAR MEDICINE 2023. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CAVOTRICUSPID ISTHMUS (CTI) - DEPENDENT ATRIAL FLUTTER (AFL) IS ONE OF THE MOST COMMON SUPRAVENTRICULAR TACHYARRHYTHMIAS. CATHETER ABLATION (CA) FOR AFL IS AN EFFECTIVE METHOD OF TREATMENT AND HAS BEEN SUCCESSFULLY USED FOR 30 YEARS. THE MOST SEVERE COMPLICATIONS ASSOCIATED WITH CA INCLUDE DEATH, STROKE, COMPLETE ATRIOVENTRICULAR BLOCK, CARDIAC TAMPONADE, ACUTE MYOCARDIAL INFARCTION, AND THROMBOEMBOLISM. THE RISK OF DEVELOPING ISCHEMIC STROKE OR PULMONARY EMBOLISM (PE) FROM ELECTROPHYSIOLOGIC PROCEDURES IS REPORTEDLY 0% TO 1.7%. OBJECTIVE(S): THE AIM OF THIS STUDY WAS TO SHARE OUR EXPERIENCE WITH THE RARE THROMBOEMBOLIC COMPLICATIONS OF CAVOTRICUSPID ISTHMUS ABLATION SUCH AS ISCHEMIC STROKE AND PULMONARY EMBOLISM. METHOD(S): WE RETRIEVED OUR DATA ABOUT PATIENTS WITH AFL WHO UNDERWENT CTI ABLATION BETWEEN 2020 AND 2022 AT OUR CENTER. INCLUSION CRITERIA WERE DOCUMENTATION OF STAND

  Patient problems: Stroke/CVA

  MAUDE report 19611743 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: OLGUN, F.E., KILICASLAN, F. (2023). RARE THROMBOEMBOLIC COMPLICATIONS OF CAVOTRICUSPID ISTHMUS ABLATION: SINGLE CENTER EXPERIENCE. E JOURNAL OF CARDIOVASCULAR MEDICINE 2023. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CAVOTRICUSPID ISTHMUS (CTI) - DEPENDENT ATRIAL FLUTTER (AFL) IS ONE OF THE MOST COMMON SUPRAVENTRICULAR TACHYARRHYTHMIAS. CATHETER ABLATION (CA) FOR AFL IS AN EFFECTIVE METHOD OF TREATMENT AND HAS BEEN SUCCESSFULLY USED FOR 30 YEARS. THE MOST SEVERE COMPLICATIONS ASSOCIATED WITH CA INCLUDE DEATH, STROKE, COMPLETE ATRIOVENTRICULAR BLOCK, CARDIAC TAMPONADE, ACUTE MYOCARDIAL INFARCTION, AND THROMBOEMBOLISM. THE RISK OF DEVELOPING ISCHEMIC STROKE OR PULMONARY EMBOLISM (PE) FROM ELECTROPHYSIOLOGIC PROCEDURES IS REPORTEDLY 0% TO 1.7%. OBJECTIVE(S): THE AIM OF THIS STUDY WAS TO SHARE OUR EXPERIENCE WITH THE RARE THROMBOEMBOLIC COMPLICATIONS OF CAVOTRICUSPID ISTHMUS ABLATION SUCH AS ISCHEMIC STROKE AND PULMONARY EMBOLISM. METHOD(S): WE RETRIEVED OUR DATA ABOUT PATIENTS WITH AFL WHO UNDERWENT CTI ABLATION BETWEEN 2020 AND 2022 AT OUR CENTER. INCLUSION CRITERIA WERE DOCUMENTATION OF STAND

  Patient problems: Heart Block; Pulmonary Embolism

  MAUDE report 19611741 ↗
• InjuryMay 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED MEDICATION AND PROLONGED HOSPITALIZATION. DURING AN AFIB PROCEDURE, THE PATIENT HAD A PRESSURE DROP AND THEN IT WAS OBSERVED THAT THE PATIENT HAD DEVELOPED A PERICARDIAL EFFUSION. THE BLOOD THINNERS (HEPARIN) WERE REVERSED, AND THE PATIENT WAS STABILIZED WITH BLOOD PRESSURE (BP) MEDICATION AND WAS TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR OBSERVATION. THERE WAS NO RADIOFREQUENCY (RF) ENERGY APPLIED DURING THE PROCEDURE (MAPPING ONLY).

  Patient problems: Cardiac Tamponade

  MAUDE report 19264264 ↗
• InjuryMay 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YANO M, EGAMI Y, KAWANAMI S, SUGAE H, UKITA K, KAWAMURA A, NAKAMURA H, YASUMOTO K, TSUDA M, OKAMOTO N, MATSUNAGA-LEE Y, NISHINO M, TANOUCHI J. RELATIONSHIP BETWEEN PRE-PROCEDURAL NON-ISCHEMIC ST-SEGMENT DEPRESSION AND THE CLINICAL OUTCOMES AFTER CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION PATIENTS. J CARDIOL. 2023 MAY;81(5):456-463. DOI: 10.1016/J.JJCC.2023.02.004. EPUB 2023 FEB 21. PMID: 36822545. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ST-SEGMENT DEPRESSION SUGGESTS THE PRESENCE OF CORONARY ARTERY DISEASE (CAD) DURING SINUS RHYTHM, BUT THE CLINICAL SIGNIFICANCE, INCLUDING THE OUTCOMES AFTER CATHETER ABLATION (CA), IN ATRIAL FIBRILLATION (AF) PATIENTS REMAIN UNKNOWN. METHODS: THE PRESENT STUDY INCLUDED PERSISTENT AF (PERAF) PATIENTS FROM THE OSAKA ROSAI ATRIAL FIBRILLATION ABLATION (ORAF) REGISTRY WHO UNDERWENT AN INITIAL ABLATION AND HAD NO HISTORY OF CAD. WE ASSIGNED THE PATIENTS BASED ON THE PRESENCE OF ST-SEGMENT DEPRESSION BEFORE CA AND EVALUATED THE IMPACT OF RELEVANT FACTORS ON STSEGMENT DEPRESSION AND THE RELATIONSHIP BETWEEN ST-SEGMENT DEPRESSION, INCLUDING LEADS LOCATIO

  Patient problems: Paralysis; Paresis

  MAUDE report 19238753 ↗
• InjuryApr 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WHICH INCLUDED A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND THE PATIENT EXPERIENCED ESOPHAGEAL PERFORATION THAT REQUIRED SURGICAL INTERVENTION. THE PATIENT WAS ADMITTED FOR ESOPHAGEAL PAIN WHEN SWALLOWING. IMAGING REVEALED AN ESOPHAGEAL PERFORATION THAT WAS DETERMINED TO BE CAUSED BY THERMAL DAMAGE. THERE WAS NO COMMUNICATION WITH THE ATRIUM. THE CARDIOTHORACIC (CT) SURGERY WAS CONSULTED BUT THEY DECLINED TO PERFORM SURGERY BECAUSE THE PATIENT'S RELIGION DOES NOT ALLOW THEM TO ACCEPT BLOOD PRODUCTS. THEY ARE STILL AT THE HOSPITAL AT THE TIME OF THE CALL, AND THEY ARE TRYING TO FIND ANOTHER HOSPITAL THAT WOULD CONSIDER DOING SURGERY ON THE PATIENT. PATIENT UNDERWENT THE PROCEDURE AT A DIFFERENT HOSPITAL THAN WHERE THEY PRESENTED WITH SYMPTOMS. PATIENT WAS TREATED FOR THE ESOPHAGEAL PERFORATION AT (B)(6) HOSPITAL.

  Patient problems: Perforation of Esophagus

  MAUDE report 19035764 ↗
• InjuryMar 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WEI HQ, CHEN W, LUO S, LIAO Z, FANG X, LIAO H, SUN Q, GUO XG, YANG JD, LIANG JJ, WU S, XUE Y, MA J, ZHAN X. COMPARISON OF STRATEGIES FOR CATHETER ABLATION OF LEFT POSTERIOR FASCICULAR VENTRICULAR TACHYCARDIA. EUROPACE. 2023 NOV 2;25(11):EUAD339. DOI: 10.1093/EUROPACE/EUAD339. PMID: 37971899; PMCID: PMC10653165. OBJECTIVE/METHODS/STUDY DATA: AIMS: TRADITIONAL ABLATION STRATEGIES INCLUDING TARGETING THE EARLIEST PURKINJE POTENTIAL (PP) DURING LEFT POSTERIOR FASCICULAR (LPF) VENTRICULAR TACHYCARDIA (VT) OR LINEAR ABLATION AT THE MIDDLE SEGMENT OF LPF DURING SINUS RHYTHM ARE COMMONLY USED FOR THE TREATMENT OF LPF-VT. CATHETER ABLATION FOR LPF-VT TARGETING FRAGMENTED ANTEGRADE PURKINJE (FAP) POTENTIAL DURING SINUS RHYTHM IS A NOVEL APPROACH. AUTHORS AIMED TO COMPARE SAFETY AND EFFICACY OF DIFFERENT ABLATION STRATEGIES (FAP ABLATION VS. TRADITIONAL ABLATION) FOR THE TREATMENT OF LPF-VT. METHODS AND RESULTS: CONSECUTIVE PATIENTS WITH ELECTROCARDIOGRAPHICALLY DOCUMENTED LPF-VT REFERRED FOR CATHETER ABLATION RECEIVED EITHER FAP ABLATION APPROACH OR TRADITIONAL ABLATION APPROACH. ELECTROPHYSIOLOGICAL

  Patient problems: Heart Block

  MAUDE report 18938492 ↗
• InjuryMar 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YADAV R, SATTI DI, MALWANKAR J, LOPEZ-SILVA C, XU L, LIEBOW-FEESER E, AKHTAR T, MARINE JE, BERGER R, CALKINS H, SPRAGG D. PERICARDITIS AFTER CATHETER ABLATION FOR ATRIAL FIBRILLATION: PREDICTORS AND OUTCOMES. JACC CLIN ELECTROPHYSIOL. 2024 FEB;10(2):262-269. DOI: 10.1016/J.JACEP.2023.09.026. EPUB 2023 NOV 29. PMID: 38032577. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CATHETER ABLATION IS A MAINSTAY OF ATRIAL FIBRILLATION (AF) TREATMENT. ACUTE PERICARDITIS AFTER ABLATION IS 1 OF THE FREQUENTLY OBSERVED COMPLICATIONS. THERE IS A SIGNIFICANT LACK OF DATA ON THE INCIDENCE AND PREDICTORS OF POSTABLATION PERICARDITIS. OBJECTIVES: THIS STUDY EXAMINES THE INCIDENCE, CHARACTERISTICS, AND PREDICTORS OF PERICARDITIS AFTER AF ABLATION. METHODS: PATIENTS UNDERGOING AF ABLATION FROM (B)(6) 2016, TO (B)(6)2022, AT (B)(6) WERE PROSPECTIVELY ENROLLED IN AN AF ABLATION REGISTRY. A CLINICAL DIAGNOSIS OF ACUTE PERICARDITIS WAS ESTABLISHED IN ACCORDANCE WITH 2015 EUROPEAN SOCIETY OF CARDIOLOGY GUIDELINES BY THE PRESENCE OF AT LEAST 2 OF THE FOLLOWING CHARACTERISTICS: PLEURITIC CHEST PAIN, FRICTION RUB, TYPICAL E

  Patient problems: Cardiac Tamponade

  MAUDE report 18936690 ↗
• InjuryMar 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YADAV R, SATTI DI, MALWANKAR J, LOPEZ-SILVA C, XU L, LIEBOW-FEESER E, AKHTAR T, MARINE JE, BERGER R, CALKINS H, SPRAGG D. PERICARDITIS AFTER CATHETER ABLATION FOR ATRIAL FIBRILLATION: PREDICTORS AND OUTCOMES. JACC CLIN ELECTROPHYSIOL. 2024 FEB;10(2):262-269. DOI: 10.1016/J.JACEP.2023.09.026. EPUB 2023 NOV 29. PMID: 38032577. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: CATHETER ABLATION IS A MAINSTAY OF ATRIAL FIBRILLATION (AF) TREATMENT. ACUTE PERICARDITIS AFTER ABLATION IS 1 OF THE FREQUENTLY OBSERVED COMPLICATIONS. THERE IS A SIGNIFICANT LACK OF DATA ON THE INCIDENCE AND PREDICTORS OF POSTABLATION PERICARDITIS. OBJECTIVES: THIS STUDY EXAMINES THE INCIDENCE, CHARACTERISTICS, AND PREDICTORS OF PERICARDITIS AFTER AF ABLATION. METHODS: PATIENTS UNDERGOING AF ABLATION FROM JANUARY 1, 2016, TO MARCH 31, 2022, AT (B)(6) WERE PROSPECTIVELY ENROLLED IN AN AF ABLATION REGISTRY. A CLINICAL DIAGNOSIS OF ACUTE PERICARDITIS WAS ESTABLISHED IN ACCORDANCE WITH 2015 EUROPEAN SOCIETY OF CARDIOLOGY GUIDELINES BY THE PRESENCE OF AT LEAST 2 OF THE FOLLOWING CHARACTERISTICS: PLEURITIC CHEST PAIN, FRICTION RUB, T

  Patient problems: Cardiac Tamponade

  MAUDE report 18936406 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: BATES A, NASEER M, TAYLOR M, DENHAM N, YUE A, DAS M, MORRIS GM, ULLAH W. A U.K. MULTICENTER RETROSPECTIVE STUDY OF THE LEARNING CURVE AND RELATIVE IMPACT ON SUCCESS RATES AND PROCEDURAL METRICS OF THE RHYTHMIA HDX¿ MAPPING SYSTEM. J INNOV CARD RHYTHM MANAG. 2023 MAY 15;14(5):5442-5450. DOI: 10.19102/ICRM.2023.14054. PMID: 37216082; PMCID: PMC10193869. OBJECTIVE/METHODS/STUDY DATA: ABSTRACT: THE LEARNING CURVE FOR THE NOVEL RHYTHMIA HDX¿ 3-DIMENSIONAL ELECTROANATOMIC SYSTEM IS UNKNOWN. RETROSPECTIVE DATA COLLECTION WAS CARRIED OUT AT 3 U.K. CENTERS FROM THE INTRODUCTION OF RHYTHMIA HDX¿ (BOSTON SCIENTIFIC, MARLBOROUGH, MA, USA) AND ASSOCIATED MAPPING AND ABLATION CATHETERS. PATIENTS WERE MATCHED WITH CONTROLS USING THE CARTO® 3 MAPPING SYSTEM (BIOSENSE WEBSTER INC., DIAMOND BAR, CA, USA). FLUOROSCOPY, RADIOFREQUENCY ABLATION, AND PROCEDURE TIMES; ACUTE AND LONG-TERM SUCCESS; AND COMPLICATIONS WERE ASSESSED. A TOTAL OF 253 STUDY PATIENTS ALONG WITH 253 CONTROLS WERE INCLUDED. SIGNIFICANT CORRELATIONS EXISTED BETWEEN PROCEDURAL EFFICIENCY METRICS AND CENTER EXPERIENCE FOR DE NOVO ATRIAL FIBRIL

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Heart Block; Ischemia Stroke; Unspecified Tissue Injury

  MAUDE report 18927521 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: WANG K, JIN C, CHEN H, YANG G, LIU H, WANG Z, JIANG X, JU W, CHEN M. GENERAL ANESTHESIA ENHANCES LESION QUALITY AND ABLATION EFFICIENCY OF CIRCUMFERENTIAL PULMONARY VEIN ISOLATION. J ARRHYTHM. 2023 NOV 27;40(1):76-82. DOI: 10.1002/JOA3.12960. PMID: 38333406; PMCID: PMC10848594. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: PULMONARY VEIN ISOLATION (PVI) IS THE CORNERSTONE OF ATRIAL FIBRILLATION (AF) ABLATION. GENERAL ANESTHESIA (GA) RESOLVES THE PROBLEM OF PAIN INTOLERABILITY AND PROVIDES REGULAR RESPIRATORY MODE WHICH MIGHT IMPROVE THE CATHETER MANEUVERABILITY OF AF ABLATION. THIS STUDY AIMS TO COMPARE THE PROCEDURAL PERFORMANCE OF PVI UNDER GA VERSUS CONSCIOUS SEDATION (CS) FROM MULTIPLE PERSPECTIVES. METHODS: A TOTAL OF 36 CONSECUTIVE PATIENTS UNDERGOING FIRST AF ABLATION UNDER GA WERE ENROLLED IN GA GROUP. ANOTHER 109 PATIENTS RECEIVING AF ABLATION UNDER CS IN THE SAME PERIOD WERE SELECTED AS THE CONTROL GROUP. AFTER PROPENSITY SCORE MATCHING, 29 MATCHED PAIRS WITH SIMILAR BASELINE CHARACTERISTICS WERE AVAILABLE FOR FURTHER ANALYSIS. THE AIFV (USING AI TO ANALYZE THE RAW DATA FROM CARTO3 SY

  Patient problems: Cardiac Tamponade; Stroke/CVA

  MAUDE report 18927506 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ZHANG S, WU Z, CHEN M, LI X, LIU Q, ZHOU S. COMPARISON BETWEEN CONVENTIONAL APPROACH AND THREE-DIMENSIONAL MAPPING SYSTEM IN THE CATHETER ABLATION OF ACCESSORY PATHWAY ASSOCIATED WITH CORONARY SINUS DIVERTICULUM: A SINGLE-CENTER EXPERIENCE. ANN NONINVASIVE ELECTROCARDIOL. 2024 JAN;29(1):E13100. DOI: 10.1111/ANEC.13100. EPUB 2023 DEC 20. PMID: 38115789; PMCID: PMC10770808. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: POSTEROSEPTAL ACCESSORY PATHWAYS (APS) ASSOCIATED WITH CORONARY SINUS (CS) DIVERTICULUM PRESENT A RARE AND CHALLENGE FOR ABLATION. THIS STUDY AIMED TO COMPARE THE SAFETY AND EFFICACY OF CONVENTIONAL APPROACH AND THREE-DIMENSIONAL (3D) MAPPING SYSTEM IN THE CATHETER ABLATION. METHODS AND RESULTS: THIS WAS A RETROSPECTIVE STUDY OF ALL PATIENTS (FROM JANUARY 2013 TO JULY 2022) WHO UNDERWENT CATHETER ABLATION OF POSTEROSEPTAL AP ASSOCIATED WITH CS DIVERTICULA IN OUR CENTER. PATIENTS WHO UNDERWENT CATHETER ABLATION USING THE TRADITIONAL FLUOROSCOPY METHOD WERE INCLUDED IN THE CONVENTIONAL METHOD GROUP (N = 13). PATIENTS WHO UNDERWENT CATHETER ABLATION USING THE 3D MAPPING METHOD WERE IN

  Patient problems: Pericardial Effusion

  MAUDE report 18927265 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YALIN K, SOYSAL AU, AKSU T, ONDER SE, OZTURK S, YALMAN H, MUTLU D, ERCAN OT, IKITIMUR B, CIMCI M, DURMAZ E, KARADAG B, BILGE AK, HUANG H, KARPUZ H. SAFETY AND EFFICACY OF CORONARY ANGIOGRAPHIC IMAGE INTEGRATION TOOL-GUIDED ABLATION OF LEFT SIDED OUTFLOW TRACT VENTRICULAR ARRHYTHMIAS. J INTERV CARD ELECTROPHYSIOL. 2024 JAN;67(1):31-34. DOI: 10.1007/S10840-023-01619-4. EPUB 2023 AUG 14. PMID: 37578671. OBJECTIVE/METHODS/STUDY DATA: AUTHORS INVESTIGATED THE SAFETY AND EFCACY OF IIT-GUIDED ABLATION OF LEFT-SIDED OUTFOW TRACT VENTRICULAR ARRHYTHMIAS (VA) AND COMPARED TO SIMULTANEOUS CONVENTIONAL ANGIOGRAPHY (SCA). THE ARTICLE REPORTS VASCULAR ACCESS SITE COMPLICATION REQUIRING SURGERY AND THESE ARE ASSOCIATED WITH THE USE OF SHEATHS AT FEMORAL ACCESS SITES. THE ARTICLE DOES NOT IDENTIFY SHEATHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL ABLATION CATHETER CONCOMITANT BIOSENSE WEBSTER DEVICES THAT WERE USED IN THIS STUDY: CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A

  Patient problems: Cardiac Tamponade; Ischemic Heart Disease

  MAUDE report 18927050 ↗
• InjuryMar 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GARDZIEJCZYK P, PIOTROWSKI R, KRYNSKI T, SIKORSKA A, KULAKOWSKI P, BARAN J. BIPOLAR CATHETER ABLATION WITH DEDICATED RADIOFREQUENCY SYSTEM FOR HIGHLY REFRACTORY VENTRICULAR ARRHYTHMIA-DOES THE RATE OF SUCCESS DEPEND ON ARRHYTHMIA ORIGIN? J CARDIOVASC ELECTROPHYSIOL. 2024 JAN 31. DOI: 10.1111/JCE.16186. EPUB AHEAD OF PRINT. PMID: 38293729. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: DESPITE RAPID TECHNOLOGICAL PROGRESS, SOME ARRHYTHMIAS ARE STILL RESISTANT TO STANDARD UNIPOLAR ABLATION. THESE INCLUDE ARRHYTHMIAS ARISING FROM THE BASE OF THE HEART, CARDIAC CRUX, OR EPICARDIUM. BIPOLAR RADIOFREQUENCY ABLATION (B-RFA) MAY BE USEFUL IN SOME CASES, HOWEVER, DATA ON THE EFFICACY OF THIS APPROACH IN VARIOUS ARRHYTHMIA LOCALIZATIONS ARE SCARCE. THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY OF B-RFA IN PATIENTS WITH VENTRICULAR ARRHYTHMIAS ORIGINATING FROM VARIOUS LOCATIONS, OCCURRING REFRACTORY TO STANDARD UNIPOLAR ABLATION APPROACHES. METHODS: AN OBSERVATIONAL, SINGLE CENTER STUDY WAS CONDUCTED OVER A 30-MONTH PERIOD. B-RFA WERE PERFORMED USING DEDICATED RADIO FREQUENCY (RF) GENERATOR AND ELECTR

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Unspecified Nervous System Problem; Unspecified Tissue Injury

  MAUDE report 18923747 ↗
• InjuryNov 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED CEREBROVASCULAR ACCIDENT THAT REQUIRED THROMBOLYTICS AND PROLONGED HOSPITALIZATION. THE PROCEDURE WAS PERFORMED ON (B)(6) 2023. POST PROCEDURE, IT WAS FOUND IN POST OPERATIVE ANESTHESIA RECOVERY THAT THE PATIENT HAD SUFFERED A DUAL HEMISPHERE STROKE. THE PATIENT WAS GIVEN THROMBOLYTICS AND HAS RESIDUAL NERO DEFICITS AND REMAINED IN THE HOSPITAL. THE PHYSICIAN NOTED NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS. THE PHYSICIAN'S OPINION ON THIS ADVERSE EVENT WAS "INTEROP ISSUE NOT DIRECTLY RELATED TO BWI PRODUCTS". PATIENT REQUIRED A TRACHEOTOMY AND "ADDITIONAL CARE". NO EVIDENCE OF CHAR, THROMBUS/CLOT DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 18085426 ↗
• InjuryOct 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: O'NEILL L, ALMORAD A, EL HADDAD M, WIELANDTS JY, GILLIS K, HILFIKER G, DE BECKER B, LYCKE M, TAVERNIER R, LE POLAIN DE WAROUX JB, DUYTSCHAEVER M, KNECHT S. IMPACT OF CATHETER ABLATION ON ARRHYTHMIA BURDEN IN PATIENTS WITH SHOCK-RESISTANT PERSISTENT ATRIAL FIBRILLATION. JACC CLIN ELECTROPHYSIOL. 2023 JUL 18:S2405-500X(23)00390-0. DOI: 10.1016/J.JACEP.2023.06.004. EPUB AHEAD OF PRINT. PMID: 37542487. OBJECTIVE/METHODS/STUDY DATA:BACKGROUND PERSISTENT SHOCK-RESISTANT ATRIAL FIBRILLATION (AF) IS A CHALLENGING ENTITY, WITH MODEST RESULTS FROM CATHETER ABLATION ACCORDING TO CONVENTIONAL SURVIVAL ANALYSIS. OBJECTIVES THE AIM OF THIS STUDY WAS TO DETERMINE THE EFFECT OF CATHETER ABLATION ON ATRIAL TACHYARRHYTHMIA (ATA) BURDEN IN PERSISTENT AF PATIENTS UNDERGOING FIRST-TIME ABLATION WITH THE USE OF AN IMPLANTABLE CARDIAC MONITOR (ICM). METHODS PATIENTS WITH DRUG-RESISTANT ONGOING PERSISTENT AF AND AT LEAST 1 PREVIOUS FAILED CARDIOVERSION WERE IMPLANTED WITH AN ICM 2 MONTHS BEFORE THE PROCEDURE. ALL PATIENTS UNDERWENT PULMONARY VEIN ISOLATION WITH OR WITHOUT ADDITIONAL SUBSTRATE ABLATION DEPENDING ON

  Patient problems: Heart Failure/Congestive Heart Failure; Pericarditis

  MAUDE report 17959559 ↗
• InjuryOct 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: LIN, Y.-F.; XU, Q.; ZHENG, C.;SHAO, J.-M.; SHEN, B.; HE, R.-L.; LIN,J.-F.; CHEN, Y.-R. ELECTROCARDIOGRAPHIC CHARACTERISTICS OF VENTRICULAR ARRHYTHMIAS ORIGINATING FROM DIFFERENT AREAS ADJACENT TO THEMITRAL ANNULUS. J. CARDIOVASC. DEV. DIS. 2023, 10, 334. HTTPS://DOI.ORG/ 10.3390/JCDD10080334 OBJECTIVE/METHODS/STUDY DATA: THIS STUDY AIMED TO EXPLORE THE ELECTROCARDIOGRAPHIC (ECG) CHARACTERISTICS OF VENTRICULAR ARRHYTHMIAS (VAS) ARISING FROM EPICARDIAL AND ENDOCARDIAL AREAS ADJACENT TO THE MITRAL ANNULUS (MA). METHODS: THIS RETROSPECTIVE STUDY ANALYZED 3435 PATIENTS REFERRED FOR RFCA FOR VAS TO THE SECOND AFFILIATED HOSPITAL AND YUYING CHILDREN¿S HOSPITAL OF WENZHOU MEDICAL UNIVERSITY FROM JANUARY 2009 TO SEPTEMBER 2021. THE ORIGIN SITES WERE LOCATED IN AREAS ADJACENT TO THE MA IN 283 PATIENTS (8.24%). THESE 283 CASES INCLUDED 132 ENDOCARDIUM CASES AND 151 EPICARDIUM CASES. .THE ECG CHARACTERISTICS OF THESE PATIENTS WERE ANALYZED RETROSPECTIVELY. ALL CASES HAD FREQUENT PVCS/VT (DEFINED AS PVCS MORE THAN 10,000 COUNTS/24 H) OR SEVERE CLINICAL SYMPTOMS INTOLERABLE TO AT LEAST TWO ANTIARRHYT

  Patient problems: Cardiac Tamponade; Vasoconstriction

  MAUDE report 17958867 ↗
• InjuryOct 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JOHN RM, TEDROW U, TADROS T, RICHARDSON TD, KANAGASUNDRAM A, HOFFMAN RD, KAPP ME, SHAH A, MICHAUD G, STEVENSON W. INTRAMYOCARDIAL HEMATOMA DURING CATHETER ABLATION FOR SCAR-RELATED VENTRICULAR TACHYCARDIA. JACC CLIN ELECTROPHYSIOL. 2023 AUG 11:S2405-500X(23)00516-9. DOI: 10.1016/J.JACEP.2023.07.004. EPUB AHEAD OF PRINT. PMID: 37632506. OBJECTIVE/METHODS/STUDY DATA:THE GOAL OF THIS STUDY WAS TO DESCRIBE THE FEATURES AND OUTCOMES OF INTRAMURAL HEMATOMA DURING ABLATION FOR SCAR-RELATED VT. THREE OF THE FOUR CASES INVOLVED BIOSENSE WEBSTER PRODUCTS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CASE #1 POSSIBLY ASSOCIATED WITH UNIDENTIFIED BIOSENSE WEBSTER DF CURVE ST/SF (CONTACT FORCE SENSING): QTY 1 BASAL INFEROLATERAL LEFT VENTRICLE HEMATOMA (HEMATOMA) TREATED WITH PERICARDIOCENTESIS, EMERGENCY STERNOTOMY AND PROCOAGULANT COLLAGEN PATCH (SURGICAL INTERVENTION). PATIENT OUTCOME IS DISCHARGED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CASE #2 POSSIBLY ASSOCIATED WITH UNIDENTIFIED BIOSENSE WEBSTER THERMOCOOL DF CURVE ST (CONTACT FORCE SENSING): QTY 1 MID TO DISTAL LATERAL LEFT VENTRICLE HEMATOM

  Patient problems: Hematoma

  MAUDE report 17951079 ↗
• InjurySep 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT EXPERIENCED A HEMOTHORAX. IT WAS REPORTED THAT POST PROCEDURE, WHILE THE PATIENT WAS IN THE RECOVERY ROOM, THE PATIENT COMPLAINED OF RIGHT SHOULDER AND RIB PAIN. AN X-RAY WAS TAKEN AND SUGGESTED THAT THE PATIENT HAD A HEMOTHORAX WHICH WAS THEN CONFIRMED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN. A CHEST TUBE WAS INSERTED FOR DRAINAGE. THE ADVERSE EVENT DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. ALL FORCE VISUALIZATION FEATURES WERE USED (GRAPH, DASHBOARD, VECTOR, VISITAG). VISITAG MODULE WAS USED AND THE PARAMETERS FOR STABILITY USED WERE 2.5MM, 3 SEC, 25% OVER 3G. NO ADDITIONAL FILTER USED WITH THE VISITAG. SURPOINT TAG INDEX WAS USED

  Patient problems: Pulmonary Dysfunction

  MAUDE report 17822718 ↗
• InjuryAug 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TEDROW UB, KURATA M, KAWAMURA I, BATNYAM U, DUKKIPATI S, NAKAMURA T, TANIGAWA S, FUJI A, RICHARDSON TD, KANAGASUNDRAM AN, KORUTH JS, JOHN RM, HASEGAWA K, ABDELWAHAB A, SAPP J, REDDY VY, STEVENSON WG. WORLDWIDE EXPERIENCE WITH AN IRRIGATED NEEDLE CATHETER FOR ABLATION OF REFRACTORY VENTRICULAR ARRHYTHMIAS: FINAL REPORT. JACC CLIN ELECTROPHYSIOL. 2023 AUG;9(8 PT 2):1475-1486. DOI: 10.1016/J.JACEP.2023.05.014. EPUB 2023 MAY 19. PMID: 37278684. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND WE PREVIOUSLY REPORTED FEASIBILITY OF IRRIGATED NEEDLE ABLATION (INA) WITH A RETRACTABLE 27-G END-HOLE NEEDLE CATHETER TO TREAT NONENDOCARDIAL VENTRICULAR ARRHYTHMIA SUBSTRATE, AN IMPORTANT CAUSE OF ABLATION FAILURE. OBJECTIVES THE PURPOSE OF THIS STUDY WAS TO REPORT OUTCOMES AND COMPLICATIONS IN OUR ENTIRE INA-TREATED POPULATION. METHODS PATIENTS WITH RECURRENT SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) OR HIGH-DENSITY PREMATURE VENTRICULAR CONTRACTIONS (PVCS) DESPITE RADIOFREQUENCY ABLATION WERE PROSPECTIVELY ENROLLED AT 4 CENTERS. ENDPOINTS INCLUDED A 70% DECREASE IN VT FREQUENCY OR PVC BURDEN DECREASE

  Patient problems: Cardiac Tamponade; Heart Block; Pleural Effusion; Pulmonary Embolism

  MAUDE report 17663427 ↗
• InjuryAug 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JUL;9(7 PT 2):1013-1023. DOI: 10.1016/J.JACEP.2022.12.011. EPUB 2023 JAN 18. PMID: 36752455. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND ALTHOUGH CATHETER ABLATION (CA) IS SUCCESSFUL FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION (AF), RESULTS ARE LESS SATISFACTORY IN PERSISTENT AF. HYBRID ABLATION (HA) RESULTS IN BETTER OUTCOMES IN PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION (PERSAF), AS IT COMBINES A THORACOSCOPIC EPICARDIAL AND TRANSVENOUS ENDOCARDIAL APPROACH IN A SINGLE PROCEDURE. OBJECTIVES THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTIVENESS AND SAFETY OF HA WITH CA IN A PROSPECTIVE, SUPERIORITY, UNBLINDED, RANDOMIZED CONTROLLED TRIAL. METHODS FORTY-ONE ABLATION-NAIVE PATIENTS WITH (LONG-STANDING)-PERSAF WERE RANDOMIZED TO HA (N ¼ 19) OR CA (N ¼ 22) AND RECEIVED PULMON

  Patient problems: Cardiac Tamponade

  MAUDE report 17655988 ↗
• InjuryAug 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE-THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED- DE POTTER T, SARKOZY A, DUYTSCHAEVER M, BULAVA A. SAFETY AND EFFICACY OF CATHETER ABLATION ON PATIENTS WITH PERSISTENT ATRIAL FIBRILLATION BY TARGETING REPETITIVE ACTIVATION PATTERNS AND FOCAL IMPULSES. PACING CLIN ELECTROPHYSIOL. 2023 JUL;46(7):729-737. DOI: 10.1111/PACE.14708. EPUB 2023 MAY 20. PMID: 37208935. OBJECTIVE/METHODS/STUDY DATA:THE STUDY IS INTENDED TO EVALUATE THE ACUTE AND LONG-TERM EFFECTIVENESS AND PERI-PROCEDURAL SAFETY IN ABLATION OF PERSISTENT ATRIAL FIBRILLATION (PSAF) USING THE CARTOFINDER ALGORITHM GUIDED ABLATION (CFGA) TARGETING ON REPETITIVE ACTIVATION PATTERNS (RAPS) AND FOCAL IMPULSES (FIS) IDENTIFIED IN DYNAMIC MAPS.SIXTY-FOUR PSAF PATIENTS (AGE, 60.7 ± 9.1 YEARS; MALE, 76.6%; MEDIAN PSAF DURATION, 6.0 MONTHS) UNDERWENT CFGA ON RAPS/FIS. SIX PATIENTS (9.4%) REPORTED PRIMARY ADVERSE EVENT (PAE) INCLUDING GROIN HEMATOMA (2), COMPLETE HEART BLOCK (1), TAMPONADE (1), PERICARDITIS (1), AND PSEUDOANEURYSM (1). REPEATED MAPPING AND ABLATION ON RAPS/FIS RESULTED IN THE CYCLE LENGTH (CL) INCREASE FROM 191.0 ± 167.6 MS AT BASELINE TO 365.7 ± 296.7 MS IN THE LA AND FROM 167

  Patient problems: Cardiac Tamponade; Heart Block; Pericarditis

  MAUDE report 17645544 ↗
• InjuryJul 18, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL. THE PATIENT SUFFERED A HEART BLOCK AV. IT WAS REPORTED THAT PATIENT PRESENTED A VENTRICULAR EXTRA SYSTOLE COMING FROM THE OUTFLOW TRACT. THE ORIGIN OF THE VENTRICULAR EXTRA SYSTOLE WAS IDENTIFIED IN THE LEFT OUTFLOW TRACT. THE EARLIEST POINT WAS ABLATED USING A THERMOCOOL SMARTTOUCH CATHETER WITH 30W. FEW SECONDS AFTER THE ABLATION, THE PATIENT DISPLAYED A JUNCTIONAL RHYTHM; THEREFORE, THE ABLATION WAS IMMEDIATELY TERMINATED. AFTER ABLATION, THE PATIENT DISPLAYED AN AV NODE BLOCK 1 AND A SUBSTITUTIVE RHYTHM. THE PHYSICIAN DECIDED TO IMPLANT A TWO CHAMBER PACEMAKER. PATIENT WAS STABLE DURING THE WHOLE PROCEDURE. NO EMERGENCY PACING WAS NEEDED AS ITS SUBSTITUTIVE RHYTHM WAS SUFFICIENT FOR NORMAL HEART FUNCTION. IT IS IN THE OPINION OF THE PHYSICIAN THAT THE COMPLICATION WAS NOT CAUSED BY A MALFUNCTION OF A DEVICE, BUT RATHER DUE TO HUMAN ERROR. PATIENT PRESENTED AN AV BLOCK 1 AND THEREFORE, THE PHYSICIAN DECIDED TO IMPLANT A TWO CHAMBER PACEMAKER. ADDITIONAL INFORMATION WAS RECEIVED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT PATIENT CONDITION AND HUMA

  Patient problems: Heart Block

  MAUDE report 17344116 ↗
• InjuryJun 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DHRUVA SS, ZHANG S, CHEN J, NOSEWORTHY PA, DOSHI AA, AGBOOLA KM, HERRIN J, JIANG G, YU Y, CAFRI G, COLLISON FARR K, ERVIN KR, ROSS JS, COPLAN PM, DROZDA JP JR. SAFETY AND EFFECTIVENESS OF A CATHETER WITH CONTACT FORCE AND 6-HOLE IRRIGATION FOR ABLATION OF PERSISTENT ATRIAL FIBRILLATION IN ROUTINE CLINICAL PRACTICE. JAMA NETW OPEN. 2022 AUG 1;5(8):E2227134. DOI: 10.1001/JAMANETWORKOPEN.2022.27134. PMID: 35976649; PMCID: PMC9386540. OBJECTIVE/METHODS/STUDY DATA:TO USE HEALTH SYSTEM DATA TO COMPARE THE SAFETY AND EFFECTIVENESS OF THE CF-I6 CATHETER FOR PERSISTENT AF ABLATION WITH THE THERMOCOOL SMARTTOUCH SURROUNDFLOW CATHETER (ABLATION CATHETER WITH CONTACT FORCE AND 56-HOLE IRRIGATION [CF-I56]), WHICH IS APPROVED BY THE FDA FOR THIS INDICATION. THIS RETROSPECTIVE, COMPARATIVE-EFFECTIVENESS COHORT STUDY INCLUDED PATIENTS UNDERGOING CATHETER ABLATION FOR PERSISTENT AF AT MERCY HEALTH OR MAYO CLINIC FROM (B)(6) 2014, TO (B)(6) 2021, WITH UP TO A 1-YEAR FOLLOW-UP USING ELECTRONIC HEALTH RECORD DATA. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOC

  Patient problems: Pericarditis; Pulmonary Edema; Stroke/CVA

  MAUDE report 17187738 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: VAN DER HEIJDEN CAJ, WEBERNDÖRFER V, VROOMEN M, LUERMANS JG, CHALDOUPI SM, BIDAR E, VERNOOY K, MAESSEN JG, PISON L, VAN KUIJK SMJ, LA MEIR M, CRIJNS HJGM, MAESEN B. HYBRID ABLATION VERSUS REPEATED CATHETER ABLATION IN PERSISTENT ATRIAL FIBRILLATION: A RANDOMIZED CONTROLLED TRIAL. JACC CLIN ELECTROPHYSIOL. 2023 JAN 10:S2405-500X(22)01143-4. DOI: 10.1016/J.JACEP.2022.12.011. EPUB AHEAD OF PRINT. PMID: 36752455. OBJECTIVE/METHODS/STUDY DATA:THE PURPOSE OF THIS STUDY WAS TO COMPARE THE EFFECTIVENESS AND SAFETY OF HA WITH CA IN A PROSPECTIVE, SUPERIORITY, UNBLINDED, RANDOMIZED CONTROLLED TRIAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: HYBRID PROCEDURE (HA): 3.5-MM TIP ABLATION CATHETER (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER) OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CATHETER ABLATION (CA): AN IRRIGATED TIP CONTACT FORCE MAPPING CATHETER (THERMOCOOL SMARTTOUCH, BIOSENSE WEBSTER), AUTOMATED LESION TAGGING (VISITAG, BIOSENSE WEBSTER) NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED

  Patient problems: Insufficient Information; Pericarditis

  MAUDE report 17168732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030031, P040036. One submission often covers many models, so check the product and lot details in each record.

• Z-0169-2023 · Sep 7, 2022 · Open, Classified
  THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in con
• Z-0139-2015 · Oct 19, 2014 · Terminated
  ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
• Z-0983-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0980-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0981-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0982-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0979-2012 · Nov 22, 2010 · Terminated
  EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Cat
• Z-0057-06 · Aug 8, 2005 · Terminated
  Thermocool Irrigated Catheters Celsius LABEL US Part Number# EU CATALOG # L-1189-01-S D17TCBLRT 35Q-13R PMA; L-1189-02-S D17TCDLRT 35Q-33R PMA; L-1189-03-S D17TCFLRT 35Q-53R P