ThermoCool SmartTouch D133601Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 10846835008982), received between Jun 16, 2016 and Sep 29, 2026 — classified as 10 deaths, 92 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (37 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 162 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50941074 ↗
• InjuryApr 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED A STROKE THAT REQUIRED THROMBECTOMY AND PROLONGED HOSPITALIZATION. AFTER THE ABLATION PROCEDURE WITH THE CARTO NAVIGATION SYSTEM (APPROX. 30 MIN AFTER WAKING UP FROM ANESTHESIA), THE PATIENT WAS IN THE RECOVERY UNIT AND SHOWED SIGNS COMPATIBLE WITH A STROKE. THE PATIENT COULD NOT MOVE HIS RIGHT ARM OR SPEAK CLEARLY. A CT SCAN WAS QUICKLY PERFORMED TO VERIFY WHETHER IT WAS A THROMBUS OR A HEMORRHAGE. IT WAS CONFIRMED THAT THERE WAS A THROMBUS AND A THROMBECTOMY WAS PERFORMED, THROUGH WHICH THE THROMBUS WAS REMOVED. THE PATIENT WAS RECOVERING. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION.

  Patient problems: Stroke/CVA

  MAUDE report 24918186 ↗
• InjuryApr 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED EXTENDED HOSPITALIZATION. IT WAS REPORTED THAT THE PROCEDURE WAS "LINEAR" WITHOUT COMPLICATIONS OR EVENTS TO HIGHLIGHT. HOWEVER, AFTER A FEW HOURS OF FINISHING THE PROCEDURE AND WHEN THE PATIENT WAS NO LONGER IN THE ROOM, HE BEGAN TO FEEL ILL AND WAS TACHYCARDIC. THEY DID AN ULTRASOUND TO CHECK AND THEY SAW AN EFFUSION, WHICH COULD BE DUE TO A TAMPONADE THAT OCCURRED DURING THE PROCEDURE. THE PATIENT WAS STABLE AND DID NOT REQUIRE SURGERY; HOWEVER, EXTENDED HOSPITALIZATION WAS REQUIRED. FOLLOW UP WAS REQUESTED TO DETERMINE IF THERE WAS ANY PRODUCT MALFUNCTION AS IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON "FOR AN ATRIAL FIBRILLATION NETWORK WITH THE CARTO 3 SYSTEM AND WITH BIOSENSE WEBSTER MATERIAL HAD BECOME BLOCKED."

  Patient problems: Cardiac Tamponade

  MAUDE report 24881653 ↗
• DeathFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (PAF) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION, CARDIAC ARREST, HEMATOMA AND BLEEDING. THE PATIENT DID NOT RECOVER AND DIED. THE REPORT INDICATED THAT AT THE END OF A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE OF THE ANTERIOR PAPILLARY MUSCLE USING THERMOCOOL SMARTTOUCH CATHETER, THE PATIENT EXPERIENCED ST-SEGMENT ELEVATION WHICH WAS OBSERVED ON THE ELECTROCARDIOGRAM (ECG). GIVEN THE CONCERN THAT A CORONARY ARTERY MIGHT HAVE BEEN AFFECTED, CARDIAC CATHETERIZATION WAS PERFORMED, WHICH RULED OUT ANY CORONARY INVOLVEMENT. SUBSEQUENTLY, IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT SUFFERED TWO CARDIAC ARRESTS. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING HEMATOMA, AND CARDIAC SURGEONS PROCEEDED WITH SURGICAL INTERVENTION. THEY OBSERVED HEMORRHAGE THAT HAD ALREADY CLOTTED IN THE PERICARDIUM AND THE BLEEDING ORIGINATED FROM THE POSTERIOR PART OF THE HEART, ALTHOUGH THEY WERE UNABLE TO VISUALIZE CLEARLY THE ORIGIN. THE PATIENT DID NOT RECOVER AND DIED. THE PATIENT HAD AN AORTIC VALVE PROSTHESIS AND A MITRAL VALVE PROSTHESIS

  Patient problems: Cardiac Arrest; Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemic Heart Disease

  MAUDE report 24330194 ↗
• MalfunctionJan 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. INITIALLY, THE PHYSICIAN REPORTED A PRODUCT ISSUE. NO PATIENT CONSEQUENCE WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 06-JAN-2026, OBSERVED THE PEBAX WRINKLED AND A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION ON 06-JAN-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196848 ↗
• MalfunctionJan 27, 2026Device Sensing Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER, AND AN ELECTRODE TEMPERATURE ERROR WAS OBSERVED. CONNECTIONS WERE CHECKED AND REPLACED BUT THE PROBLEM WAS NOT RESOLVED. WHEN THE CATHETER WAS REPLACED, THE PROBLEM WAS NOT SOLVED. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, FORCE TEST AND A SCANNING ELECTRODE MICROSCOPE (SEM) OF THE RETURNED DEVICE WERE PERFORMED. VISUAL ANALYSIS REVEALED A SEPARATION BETWEEN PEBAX'S AND THE SECOND ELECTRODE. IN ADDITION, A FOREIGN MATERIAL LIKE A GREENISH-WHITE AND GRAINY TEXTURE, PRESUMABLY CORROSION, WAS OBSERVED IN THE SECOND ELECTRODE. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186336 ↗
• MalfunctionJan 13, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND AN ERROR 106, CATHETER FORCE SENSOR ERROR WAS DETECTED. THE CABLE WAS REPLACED, BUT THE ERROR PERSISTED. AFTER REPLACING THE CATHETER, THE PROBLEM WAS RESOLVED. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FORCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION, AND REDDISH MATERIAL WAS FOUND INSIDE IT. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060313 ↗
• InjuryJan 7, 2026Patient Device Interaction Problem

  A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH PERICARDIAC PUNCTURE. IT WAS REPORTED THAT AT SOME POINT A CARDIAC TAMPONADE OCCURRED. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIAC PUNCTURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION AND ADDITIONAL INFORMATION ABOUT THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Cardiac Tamponade

  MAUDE report 23991991 ↗
• MalfunctionOct 29, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND THE CATHETER BROKE, REMAINING CONNECTED BY ITS INTERNAL PART. IT WAS INDICATED THAT THE PROBLEM WAS WHEN THEY WERE TRYING TO GO INSIDE THE LEFT VENTRICLE. THEY WENT RETRO AORTIC AND THE CAROTID TRUNK WAS VERY BIG AND THE CATHETER WERE ALWAYS INSIDE OF IT. THE CATHETER DID A STRANGE CURVE AND AFTER THAT, THE PHYSICIAN PUSHED HARD TO RETIRE IT FROM THE BODY. IN THIS MANEUVER, AND WITH A STRANGE LOOP, THE CATHETER BROKE, REMAINING CONNECTED BY ITS INTERNAL PART. IT WAS POSSIBLE TO REMOVE IT FROM THE PATIENT WITHOUT ANY CONSEQUENCE. AN ANGIOTAC WAS PERFORMED TO SEE IF THE VESSELS WERE OKAY AND EVERYTHING WAS OKAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THERE WERE NO LIFTED OR SHARP RINGS; HOWEVER, WIRES WERE BEING EXPOSED. THE ISSUE WAS FOUND APPROXIMATELY 15 CM FROM THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420737 ↗
• MalfunctionApr 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE PEBAX AS BROKEN AND THERE WAS A SEPARATION BETWEEN THE PEBAX AND THE ELECTRODE SECTION. INITIALLY, IT WAS REPORTED THAT THERE WAS A FORCE CATHETER SENSOR ERROR. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE FORCE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 25-MAR-2025, A HOLE WAS OBSERVED ON THE PEBAX SURFACE WITH REDDISH MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 25-MAR-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878275 ↗
• MalfunctionDec 4, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE WITH A THERMOCOOL SMARTTOUCH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION. INITIALLY, IT WAS REPORTED THAT THERE WAS NOISE ON DISTAL RINGS. TO COMPLETE THE PROCEDURE, THE PHYSICIAN USED ANOTHER PRODUCT OF THE SAME TYPE. THERE WAS NO PATIENT CONSEQUENCE. THE SIGNAL NOISE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 11-NOV-2024, A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION WAS OBSERVED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 11-NOV-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849738 ↗
• MalfunctionNov 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A SEPARATION BETWEEN THE PEBAX AND ELECTRODE SECTION. DURING THE PROCEDURE, THE MEDICAL TEAM IDENTIFIED "HI" FORCE AND THE ABLATION WOULD STOP ITSELF IMMEDIATELY. NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595708 ↗
• MalfunctionOct 22, 2024Insufficient Cooling; Obstruction of Flow; Insufficient Cooling; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. THE THERMOCOOL SMARTTOUCH CATHETER IRRIGATION CONNECTION WAS OBSTRUCTED. DURING THE PROCEDURE, ABRUPTLY AFTER DOING ABLATION OF RIGHT VEINS, WHEN THE PHYSICIAN TRIED TO ABLATE, THE CATHETER TEMPERATURE RAISED TO 50ºC AND NO ABLATION COULD BE PERFORMED. CHANGED CONNECTOR AND THE SAME OCCURRED. THE PHYSICIAN TOOK THE CATHETER OUTSIDE OF THE PATIENT TO SEE IF THE IRRIGATION HOLES WERE OBSTRUCTED. THEY SAW THAT THE CATHETER WAS NOT IRRIGATING; HOWEVER, NO ERRORS APPEARED. THEY REALIZED THAT THE IRRIGATION CONNECTION OF THE CATHETER WAS OBSTRUCTED AND NO FLOW COULD PASS. CHANGED THE CATHETER AND THE ERROR WAS SOLVED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE TEMPERATURE CUT-OFF VALUE WAS REACHED; HOWEVER, WHEN IT ARRIVED AT THE CUT-OFF, IT STOPPED THE ABLATION. THE GENERATOR WAS SET TO POWER CONTROL MODE, TEMPERATURE THRESHOLD: WARNING WAS 43ºC, CUT OFF: 50ºC AND IMPEDANCE CUT-OFF: 250 OHMS. THE OCCLUSION WAS NOT DUE TO FOREIGN MATERIAL OR PHYSICAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20511583 ↗
• MalfunctionSep 6, 2024Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE IN THE PEBAX. DURING THE PROCEDURE, THE CATHETER FORCE PRESENTED AN ISSUE. THE MEDICAL TEAM NEEDED TO RECALIBRATE SEVERAL TIMES AND THE WARNING OF ANOTHER CATHETER CONTACT CONSTANTLY SHOWED WHILE NO OTHER CATHETER WAS INSIDE THE HEART. THE MEDICAL TEAM CHANGED THE CONNECTIONS AND THE CATHETER WHICH RESOLVED THE ISSUE. THERE WAS BLOOD INSIDE THE CATHETER SPRING. THERE WAS NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163956 ↗
• InjuryAug 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED CARDIAC SURGERY. DURING A PAROXYSMAL AF ABLATION, THE PATIENT SUFFERED A CARDIAC TAMPONADE. THE PROCEDURE WAS STOPPED AND NOT SUCCESSFULLY COMPLETED. THE PATIENT NEEDED CARDIAC SURGERY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 20011366 ↗
• MalfunctionJun 28, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A SEPARATION BETWEEN PEBAX AND ELECTRODE SECTION AND THERE WAS FOREIGN MATERIAL INSIDE IT. INITIALLY, IT WAS REPORTED THAT THE CATHETER DID NOT ALLOW TO DO ZEROING FOR CONTACT FORCE. THE CONNECTOR FROM CATHETER TO PATIENT INTERFACE UNIT (PIU) WAS CHANGED TWICE AND THE ISSUE PERSISTED. CHANGING THE CONNECTOR ONLY DERIVED THE ISSUE TO THE FOLLOWING: ZERO OF FORCE COULD BE DONE BUT IT SHOWED AS THE CATHETER WAS INSIDE THE SHEATH ALL THE TIME WHILE IT WAS INDEED FLOATING WITHOUT NO SHEATH INSIDE. NO MORE CONNECTORS WERE AVAILABLE. BY CHANGING THE CATHETER, THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE FORCE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON (B)(6)2024, THERE WAS PEBAX DAMAGE AND FOREIGN MATERIAL INSIDE. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638547 ↗
• InjuryJun 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: LV J, WANG R, YANG J, YOU L, YANG C, ZHANG Y, LIU Q, YIN L, LIU JT, XIE RQ. LEFT ATRIAL APPENDAGE CLOSURE IN CONJUNCTION WITH RADIOFREQUENCY ABLATION: EFFECTS ON LEFT ATRIAL FUNCTIONING IN PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION. OPEN MED (WARS). 2024 APR 12;19(1):20240951. DOI: 10.1515/MED-2024-0951. PMID: 38623457; PMCID: PMC11017190. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVE IN THE PRESENT STUDY, WE INVESTIGATED THE IMPACT OF LEFT ATRIAL APPENDAGE CLOSURE (LAAC) FOLLOWING CATHETER ABLATION (CA) ON THE LEFT ATRIAL STRUCTURE AND FUNCTIONING OF PATIENTS WITH PAROXYSMAL ATRIAL FIBRILLATION (AF). METHODS PATIENTS WITH PAROXYSMAL AF WERE ENROLLED IN THIS SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN APRIL 2015 AND JULY 2021; 353 PATIENTS RECEIVED CA ALONE, WHILE 93 PATIENTS RECEIVED CA IN COMBINATION WITH WATCHMAN LAAC. WE USED AGE, GENDER, CHA2DS2-VASC, AND HAS-BLED SCORES AS WELL AS OTHER DEMOGRAPHIC VARIABLES TO PERFORM PROPENSITY SCORE MATCHING. PATIENTS WITH PAROXYSMAL AF WERE RANDOMLY ASSIGNED TO THE CA COMBINED WITH WATCHMAN LAAC GROUP (COMBINED TREATMENT GROUP) AND THE SIMPLE CA GR

  Patient problems: Cardiac Tamponade; Hemoptysis

  MAUDE report 19633325 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KURATA M, BATNYAM U, TEDROW UB, RICHARDSON TD, KANAGASUNDRAM AN, HASEGAWA K, UETAKE S, MANUELIAN D, PELLEGRINI C, STEVENSON WG. INTRAMURAL NEEDLE ABLATION OR REPEATED STANDARD ABLATION IN PATIENTS REFERRED FOR REPEAT ABLATION OF SCAR-RELATED VENTRICULAR TACHYCARDIA. J CARDIOVASC ELECTROPHYSIOL. 2024 MAY;35(5):994-1004. DOI: 10.1111/JCE.16250. EPUB 2024 MAR 19. PMID: 38501333. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: WHEN VENTRICULAR TACHYCARDIA (VT) RECURS AFTER STANDARD RF ABLATION (SRFA) SOME PATIENTS BENEFIT FROM REPEAT SRFA, WHEREAS OTHERS WARRANT ADVANCED METHODS SUCH AS INTRAMURAL NEEDLE ABLATION (INA). OUR OBJECTIVES ARE TO ASSESS THE UTILITY OF REPEAT SRFA AND TO CLARIFY THE BENEFIT OF INA WHEN REPEAT SRFA FAILS IN PATIENTS WITH VT DUE TO STRUCTURAL HEART DISEASE. METHODS: IN CONSECUTIVE PATIENTS WHO WERE PROSPECTIVELY ENROLLED IN A STUDY FOR INA FOR RECURRENT SUSTAINED MONOMORPHIC VT DESPITE SRFA, REPEAT SRFA WAS CONSIDERED FIRST. INA WAS PERFORMED DURING THE SAME PROCEDURE IF REPEAT SRFA FAILED OR NO TARGETS FOR SRFA WERE IDENTIFIED. RESULTS: OF 85 PATIENTS ENROLLED, ACUTE SUCC

  Patient problems: Cardiac Tamponade

  MAUDE report 19620499 ↗
• InjuryJun 26, 2024Off-Label Use; Patient Device Interaction Problem; Off-Label Use; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: PETR PEICHI, ALAN BULAVA, DAN WICHTERIE; PREDRAG STOJADINOVIC; EVA BORISINCOVA; PETER STIAVNICK Y; JANA HA SKOV A; ROBERT CIH AK AND JOSEF KAUTZNER. (MAY 2024). ACUTE EFFICACY AND SAFETY OF PULSED FIELD ABLATION FOR VENTRICULAR ARRHYTHMIA: TWOCENTER EXPERIENCE. HEART RHYTHM, VOL 21, NO5S. OBJECTIVE/METHODS/STUDY DATA: [BACKGROUND: A NOVEL PULSED FIELD (PF) ENERGY SOURCE IS A POTENTIAL OPTION FOR CATHETER ABLATION OF VENTRICULAR ARRHYTHMIAS (VA) AS IT CAN CREATE DEEPER LESIONS, PARTICULARLY IN SCARRED TISSUE. HOWEVER, ONLY LIMITED DATA EXIST REGARDING ITS EFFICACY AND SAFETY. OBJECTIVE: THIS STUDY PRESENTS THE INITIAL EXPERIENCE WITH VA ABLATION USING PF. METHODS: THE STUDY GROUP CONSISTED OF 31 PATIENTS (11 WOMEN, AGED: 61616YEARS) WITH EITHER FREQUENT VENTRICULAR ECTOPY (39%) OR SUSTAINED VA (61%). A TOTAL OF 58% OF PATIENTS HAD FAILED PREVIOUS RADIOFREQUENCY ABLATION OF VA. THE MEAN LV EJECTION FRACTION WAS 42614%. ABLATION WAS PERFORMED USING AN IRRIGATED 4-MM TIP CATHETER (THERMOCOOL SMARTTOUCHTM, BIOSENSEWEBSTER, INC.) IN COMBINATION WITH A COMMERCIALLY AVAILABLE PF GENERATOR (CENTAURI

  Patient problems: Heart Block

  MAUDE report 19619330 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JIANG Z, GUO C, LIU Q, TIAN Y, TIAN L, YANG Y, WANG J, CHEN C, ZHENG Y, LI Y, OU Q, YANG L. OUTCOMES OF SINGLE-PROCEDURE RADIOFREQUENCY CATHETER ABLATION FOR IDIOPATHIC VENTRICULAR ARRHYTHMIAS: A SINGLE-CENTRE RETROSPECTIVE COHORT STUDY. BMJ OPEN. 2024 FEB 20;14(2):E081815. DOI: 10.1136/BMJOPEN-2023-081815. PMID: 38382956; PMCID: PMC10882318. OBJECTIVE/METHODS/STUDY DATA: OBJECTIVES: RADIOFREQUENCY CATHETER ABLATION IS THE FIRST-LINE TREATMENT FOR IDIOPATHIC PREMATURE VENTRICULAR COMPLEXES (PVCS) AND VENTRICULAR TACHYCARDIAS (VTS). HOWEVER, THE OUTCOMES WERE LESS COMPARED AMONG THE CATEGORIES. THE STUDY AIMS TO ASSESS THE EFFECTIVENESS AND SAFETY OF CATHETER ABLATION FOR IDIOPATHIC PVC/VTS IN A SINGLE HIGH-VOLUME CENTRE, USING THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AS A REFERENCE. DESIGN: RETROSPECTIVE COHORT STUDY. SETTING: PATIENT DATA WERE COLLECTED FROM A TERTIARY HOSPITAL IN GUIZHOU, CHINA. PARTICIPANTS: BETWEEN SEPTEMBER 2013 AND SEPTEMBER 2022, 1028 PATIENTS (MALE: 41.3%; AGE: 46.5±15.6 YEARS) WHO UNDERWENT THE FIRST CATHETER ABLATION FOR IDIOPATHIC MONOMORPHIC PVC/VTS WERE ENROL

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Stroke/CVA

  MAUDE report 19619014 ↗
• DeathJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ¿I¿EK D, MRAK M, JAN M, ZUPAN ME¿NAR A, IVANOVSKI M, ¿LAHTIC T, KAJDIC N, ANTOLIC B, KLEMEN L, SKALE R, AVRAMOVIC GREGORIC J, ¿TUBLAR J, PERNAT A, ¿INKOVEC M. IMPACT OF PREVENTIVE SUBSTRATE CATHETER ABLATION ON IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR INTERVENTIONS IN PATIENTS WITH ISCHAEMIC CARDIOMYOPATHY AND INFARCT-RELATED CORONARY CHRONIC TOTAL OCCLUSION. EUROPACE. 2024 MAY 2;26(5):EUAE109. DOI: 10.1093/EUROPACE/EUAE109. (B)(6). OBJECTIVE/METHODS/STUDY DATA: AIMS PRIMARY PREVENTION PATIENTS WITH ISCHAEMIC CARDIOMYOPATHY AND CHRONIC TOTAL OCCLUSION OF AN INFARCT-RELATED CORONARY ARTERY (CTO) ARE AT A PARTICULARLY HIGH RISK OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) THERAPY OCCURRENCE. THE TRIAL WAS DESIGNED TO EVALUATE THE EFFICACY OF PREVENTIVE CTO-RELATED SUBSTRATE ABLATION STRATEGY IN ISCHAEMIC CARDIOMYOPATHY PATIENTS UNDERGOING PRIMARY PREVENTION ICD IMPLANTATION. METHODS AND RESULTS THE PREVENTIVE VT STUDY WAS A PROSPECTIVE, MULTICENTRE, RANDOMIZED TRIAL INCLUDING ISCHAEMIC PATIENTS WITH EJECTION FRACTION =40%, NO DOCUMENTED VENTRICULAR ARRHYTHMIAS (VAS), AND EVIDENCE OF SCAR REL

  Patient problems: Arrhythmia; Insufficient Information

  MAUDE report 19600296 ↗
• InjuryJun 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ¿I¿EK D, MRAK M, JAN M, ZUPAN ME¿NAR A, IVANOVSKI M, ¿LAHTIC T, KAJDIC N, ANTOLIC B, KLEMEN L, SKALE R, AVRAMOVIC GREGORIC J, ¿TUBLAR J, PERNAT A, ¿INKOVEC M. IMPACT OF PREVENTIVE SUBSTRATE CATHETER ABLATION ON IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR INTERVENTIONS IN PATIENTS WITH ISCHAEMIC CARDIOMYOPATHY AND INFARCT-RELATED CORONARY CHRONIC TOTAL OCCLUSION. EUROPACE. 2024 MAY 2;26(5):EUAE109. DOI: 10.1093/EUROPACE/EUAE109. PMID: 38657209; PMCID: PMC11086562. OBJECTIVE/METHODS/STUDY DATA: AIMS PRIMARY PREVENTION PATIENTS WITH ISCHAEMIC CARDIOMYOPATHY AND CHRONIC TOTAL OCCLUSION OF AN INFARCT-RELATED CORONARY ARTERY (CTO) ARE AT A PARTICULARLY HIGH RISK OF IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) THERAPY OCCURRENCE. THE TRIAL WAS DESIGNED TO EVALUATE THE EFFICACY OF PREVENTIVE CTO-RELATED SUBSTRATE ABLATION STRATEGY IN ISCHAEMIC CARDIOMYOPATHY PATIENTS UNDERGOING PRIMARY PREVENTION ICD IMPLANTATION. METHODS AND RESULTS THE PREVENTIVE VT STUDY WAS A PROSPECTIVE, MULTICENTRE, RANDOMIZED TRIAL INCLUDING ISCHAEMIC PATIENTS WITH EJECTION FRACTION =40%, NO DOCUMENTED VENTRICULAR ARRHYTHMIAS (VA

  Patient problems: Arrhythmia; Heart Block; Heart Failure/Congestive Heart Failure; Insufficient Information; Stroke/CVA

  MAUDE report 19599724 ↗
• InjuryApr 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: CUI YK, DONG JZ, DU X, HU R, HE L, LONG DY, BAI R, YU RH, SANG CH, JIANG CX, LIU N, LI SN, WANG W, GUO XY, ZHAO X, ZUO S, TANG RB, MA CS. OUTCOME OF CATHETER ABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE. PACING CLIN ELECTROPHYSIOL. 2022 SEP;45(9):1032-1041. DOI: 10.1111/PACE.14571. EPUB 2022 AUG 9. PMID: 35866663. OBJECTIVE/METHODS/STUDY DATA: BACKGROUND: ATRIAL FIBRILLATION (AF) AND STABLE CORONARY ARTERY DISEASE (SCAD) FREQUENTLY COEXIST. THIS STUDY AIMED TO ASSESS THE LONG-TERM OUTCOME OF CATHETER ABLATION IN PATIENTS WITH PAROXYSMAL AF AND SCAD. METHODS: IN TOTAL, 12,104 PATIENTS WITH PAROXYSMAL AF UNDERWENT CATHETER ABLATION IN THE CHINESE ATRIAL FIBRILLATION REGISTRY BETWEEN 2011 AND 2019 WERE SCREENED. A TOTAL OF 441 PATIENTS WITH SCAD WERE MATCHED WITH PATIENTS WITHOUT SCAD IN A 1:4 RATIO. THE PRIMARY ENDPOINT WAS AF RECURRENCE AFTER SINGLE ABLATION. THE COMPOSITE SECONDARY ENDPOINTS WERE THROMBOEMBOLISM, CORONARY EVENTS, MAJOR BLEEDING, ALL-CAUSE DEATH. RESULTS: OVER A MEAN FOLLOW-UP OF 46.0 ± 18.9 MONTHS, THE RECURRENCE RATE IN PATIEN

  Patient problems: Cardiac Tamponade; Heart Failure/Congestive Heart Failure; Stroke/CVA

  MAUDE report 19192390 ↗
• InjuryFeb 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. AFTER THE PROCEDURE, A ROUTINE ECHOCARDIOGRAPHY WAS PERFORMED, DURING WHICH A PERICARDIAL TAMPONADE WAS DISCOVERED. PHYSICIAN SUSPECTS THE TAMPONADE TO HAVE HAPPENED DURING ADVANCING TO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). PATIENT HAD ANOTHER MEDICAL ISSUE DUE TO WHICH THE CONDITION WORSENED. PHYSICIAN STATED THE ADDITIONAL COMPLICATION WAS UNRELATED TO THE USE OF BIOSENSE WEBSTER PRODUCTS AND THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED AND NO EVIDENCE OF STEAM POP. CORRECT SETTINGS SELECTED AND NO ERROR MESSAGES ON EQUIPMENT DURING PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 18799773 ↗
• InjuryFeb 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WHICH INCLUDED THE USE OF THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. DURING THE ABLATION PHASE (OR VALIDATION PHASE), THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED CARDIAC SURGERY. IT WAS REPORTED THAT A PERICARDIAL EFFUSION OCCURRED AFTER RE-PVI (PULMONARY VEIN ISOLATION). CATHETERS WERE THERMOCOOL SMARTTOUCH AND LASSO NAV. NO ABNORMALITIES DURING ABLATION AND MAPPING. NO STEAM POP WAS NOTICED. BLEEDING OCCURRED AFTER THE SHEATHS WERE PULLED AT THE END OF THE PROCEDURE. CATHETERS SHOW NO EXTERNAL DAMAGE. THE ABLATION WAS CARRIED OUT WITH 30W IN POWER MODE. THE PATIENT WAS TRANSFERRED TO CARDIAC SURGERY. ADDITIONAL MEDICAL INTERVENTIONS INCLUDE ADDITIONAL PROCEDURE, X-RAY, AND SURGERY. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS "A LAA TAMPONADE DURING CATHETER MANOUVERING TO REACH THE RIDGE". PATIENT FULLY RECOVERED AFTER EXTENDED HOSPITALIZATION BECAUSE SURGERY WAS NECESSARY TO REPAIR THE TAMPONADE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH HEARTSPAN (MERIT) NEEDLE. ABLATION WAS PERFORMED PRIOR TO NOTING THE PERICARDIAL EFFUSION. NO EVIDENC

  Patient problems: Cardiac Perforation

  MAUDE report 18750469 ↗

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-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-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-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-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-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