ThermoCool SF NAV BNI35DFCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10846835003208), received between Oct 12, 2016 and Dec 3, 2023 — classified as 3 deaths, 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A THERMOCOOL SMARTTOUCH SF ABLATION CATHETER EXPERIENCED CARDIAC ARREST AND REQUIRED HOSPITALIZATION. WHILE THE PHYSICIAN WAS ABLATING, HE HAD TERMINATED THE ARRHYTHMIA WITH VENTRICULAR TACHYCARDIA, BUT THE PATIENT BEGAN TO EXHIBIT LOW BLOOD PRESSURE THAT CONTINUED TO DROP. NO EVIDENCE OF STEAM POP. THE PATIENT FLAT-LINED AND WENT INTO CARDIAC ARREST. CONFIRMED THE ISSUE "WHILE LOOKING AT ICE (INTRACARDIAC ECHOCARDIOGRAPHY) AND REALIZING THE HEART WAS NOT CONTRACTING AND THERE WERE ECGS ON THE PATIENT." THE RECORDING SYSTEM SHOWED THE PATIENT GOING FROM VENTRICULAR TACHYCARDIA TO VENTRICULAR FIBRILLATION. PHYSICIAN PERFORMED CHEST COMPRESSIONS, MEDICINE WAS ADMINISTERED, THE PATIENT WAS SHOCKED WITH AN EXTERNAL DEFIBRILLATOR TWICE, AND THE PATIENT WAS FINALLY SHOCKED WITH HIS PACEMAKER SUCCESSFULLY. THE PATIENT WAS ALSO INTUBATED AND HIS HEART RATE BECAME STABLE AND THE VENTRICULAR TACHYCARDIA LEFT. PATIENT WAS HYPOTHERMIC, NOT RESPONSIVE IMMEDIATELY AFTER RESUSCITATION AND REMAINED INTUBATED FOR REST OF THE DAY. NO CARDIAC TAMPONADE OCCURRED AND THE PATIENT REQUIRED PROLONGED HOSPITALIZATION

  Patient problems: Cardiac Arrest

  MAUDE report 18253774 ↗
• InjuryOct 24, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A IDIOPATHIC VT CARDIAC ABLATION PROCEDURE UTILIZING A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION AND CARDIAC HEMATOMA AND REQUIRED HOSPITALIZATION FOR FURTHER EVALUATION. DURING THE PROCEDURE WHILE UTILIZING THE ABLATION CATHETER IN THE LEFT VENTRICLE, THE CATHETER PERFORATED INTO THE RIGHT ATRIUM DISCOVERED BY UTILIZING THE SOUNDSTAR CATHETER. THE INTRACARDIAC ECHO SHOWED A HEMATOMA WITHIN THE HEART AND THE TRANSESOPHAGEAL ECHO CONFIRMED THE HEMATOMA. THE CARDIAC SURGERY TEAM ARRIVED IN THE ROOM AND, AFTER APPROXIMATELY 20 MINUTES, THE HEMATOMA WAS EVALUATED AND DID NOT APPEAR TO BE GETTING LARGER. THE PATIENT REMAINED STABLE AND WAS TAKEN TO COMPUTED TOMOGRAPHY (CT) TO COMPLETE A SCAN. ANTICOAGULANTS WERE STOPPED AND NO FURTHER INTERVENTION WAS PERFORMED BEYOND DISCONTINUATION OF THE PROCEDURE AND SUBSEQUENT CT SCAN. PHYSICIAN'S OPINION ON CAUSE OF THE EVENT IS PATIENT CONDITION. PATIENT HAS EBSTEIN CONGENITAL HEART DEFECT ANOMALY AND THIS PROCEDURE AND THIS WOULD BE THE 7TH CARDIAC PROCEDURE BESIDES OTHER RELEVANT MEDICAL HISTORY. CORRECT SETTINGS SELECTED ON DEVICES, AND NO ERROR MESSAGES ON EQ

  Patient problems: Cardiac Perforation; Hematoma

  MAUDE report 17998866 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PERSISTENT AFIB AND ATRIAL FLUTTER- PERSISTENT ABLATION PROCEDURE WITH THERMOCOOL SF CATHETER A FEMALE PATIENT (B)(6) YEAR OLD SUFFERED HEART BLOCK REQUIRING PACEMAKER IMPLANTATION. IT WAS REPORTED BY THE CALLER THEY HAD A KNOWN DIFFICULT PROCEDURE. THE PATIENT HAD A MITRAL VALVE REPLACED WITH A MECHANICAL VALVE. THE PATIENT WAS IN PERSISTENT ATRIAL FIBRILLATION AND ATRIAL FLUTTER. THE ICE CATHETER SOUNDSTAR SHOWED SOME CALCIFICATION ON THE AORTIC VALVE WITH SCAR AND DYSFUNCTION IN THE LEFT VENTRICLE. THE CALLER ADVISED THE PHYSICIAN THAT THE PENTARAY CATHETER WAS CONTRAINDICATED FOR USE IN PATIENTS WITH A MECHANICAL VALVE. THE DOCTOR INSISTED ON USING THE PENTARAY BUT AVOIDED GOING INTO THE MITRAL VALVE. THE CALLER SUGGESTED USING THE ABLATION CATHETER STSF. THE RIGHT ATRIUM WAS MAPPED AND THEY ABLATED THE CAVOTRICUSPID (CTI) LINE WITH NO COMPLICATIONS. THEY THEN WENT TRANSSEPTAL AND MAPPED THE LEFT ATRIUM. THE PENTARAY CATHETER WAS REMOVED FROM THE BODY. THEY THEN ABLATED THE LEFT ATRIUM WITH NO COMPLICATIONS. THE ABLATION CATHETER WAS THEN IN THE RIGHT ATRIUM TO ATTEMPT TO ABLATE MULTIPLE ATRIAL FLUTTERS AND ATRIAL TACHYCARDIAS. ONE OF THE ATRIAL TACH

  Patient problems: Arrhythmia; No Code Available

  MAUDE report 10117207 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRE-PROCEDURE, PRIOR TO ANY CATHETERS BEING INSERTED, A SMALL PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). POST-PROCEDURE, DURING THE WAITING PERIOD, AND PRIOR TO CATHETER REMOVAL, THE PATIENT BECAME HYPOTENSIVE AND THE EFFUSION WAS CONFIRMED TO HAVE INCREASED VIA ICE. PERICARDIOCENTESIS YIELDED AN UNSPECIFIED VOLUME OF FLUID. BLOOD PRESSURE NORMALIZED. PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE SMALL PERICARDIAL EFFUSION IDENTIFIED PRIOR TO CATHETER INTRODUCTION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT ALTHOUGH A SMALL PERICARDIAL EFFUSION WAS IDENTIFIED PRIOR TO ABLATION, THE PHYSICIAN BELIEVED THAT THE ADVERSE EVENT WAS CAUSED BY HYPERDYNAMIC CARDIAC WALL MOT

  Patient problems: Cardiac Tamponade

  MAUDE report 7630217 ↗
• InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A CARDIAC TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 300 ML, BUT 250 ML WAS RE-INFUSED, FOR A TOTAL LOSS OF 50 ML. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE IS NO EVIDENCE OF EXTENDED HOSPITALIZATION. THERE IS NO INFORMATION REGARDING PATIENT OUTCOME. IT IS UNKNOWN DURING WHICH PHASE THE EVENT OCCURRED. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MAY HAVE BEEN RELATED TO PROCEDURE OR PATIENT CONDITION, BUT NOT RELATED TO ANY BWI PRODUCT MALFUNCTION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO SHEATH INFORMATION. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, OVERALL ABLATION TIME AT THE SITE OF INJURY, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY

  Patient problems: Cardiac Tamponade

  MAUDE report 7098233 ↗
• MalfunctionNov 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) PROCEDURE WITH A THERMOCOOL SF NAVIGATIONAL CATHETER. IT WAS REPORTED THAT CHAR WAS FOUND ON THE TIP OF THE CATHETER DURING A PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE CATHETER WAS CLEANED OFF AND USED TO FINISH THE CASE. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT ON (B)(6) 2017. THE GENERATOR WAS SET TO POWER CONTROL AT 50W MAX AND 40 DEGREES CUTOFF. THERE WERE NO ERRORS OR PRODUCT PROBLEMS NOTED. THERE WERE NO ISSUES RELATED TO TEMPERATURE OR FLOW ON THE CATHETER. IT WAS NOTED THAT THE TEMPERATURE WAS 32 DEGREES, IMPEDANCE 115OHMS, AND 40 WATTS. THEY USED 1000 HEPARIN. THEY CLARIFIED THAT THE MATERIAL FOUND ATTACHED TO THE TIP OF THE CATHETER WAS NOT CHAR, BUT COAGULUM. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. ORIGINALLY THE CHAR WAS ASSESSED AS NOT REPORTABLE. HOWEVER, SINCE WE RECEIVED CLARIFICATION THAT THE MATERIAL WAS NOT CHAR, BUT COAGULUM, THE COAGULUM HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION. THEREFORE, THE AWARENESS DATE IS RESET TO (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7062443 ↗
• InjurySep 5, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAVOTRICUSPID ISTHMUS (CTI) ABLATION PROCEDURE FOR RIGHT ATRIAL FLUTTER WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, WHILE ABLATING THE CTI LINE, A STEAM POP OCCURRED. PATIENT BECAME HYPOTENSIVE AND AN EFFUSION WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAPHY. PERICARDIOCENTESIS YIELDED APPROXIMATELY 280 ML OF BLOOD AND FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT REMAINED HOSPITALIZED FOR OBSERVATION. IT WAS NOTED THAT THE PHYSICIAN DOES NOT BELIEVE A BIOSENSE WEBSTER, INC. PRODUCT WAS RESPONSIBLE FOR THE INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 6843880 ↗
• DeathJun 7, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION AND PHARMACOLOGIC SUPPORT), THROMBOSIS (REQUIRING TISSUE PLASMINOGEN ACTIVATOR), AND DEATH. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND HYPOXIC. POST-ABLATION, THE PATIENT WAS CARDIOVERTED. PATIENT ARRESTED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. PATIENT WAS PREPARED FOR A CARDIAC CATHETERIZATION. SINCE THERE MAY HAVE BEEN A POSSIBLE EMBOLIC EVENT, TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. IT WAS NOTED THAT MYOCARDIAL STUNNING MAY HAVE OCCURRED. INTRACARDIAC ULTRASOUND AND TRANSTHORACIC ECHOCARDIOGRAM REVEALED NO PERICARDIAL EFFUSION. INITIALLY, THE PATIENT WAS REPORTED TO BE IN UNSTABLE CONDITION. PATIENT REQUIRED EXTENDED HOSPITALIZATION IN THE INTENSIVE CARE UNIT AS A RESULT OF THE ADVERSE EVENT FOR STABILIZATION AND MONITORING. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE EVENT IS THAT IT WAS POSSIBLY RELATED TO POST-ABLATION CARDIOVERSION. INJURIES HAVE NOT BEEN CONFIRMED. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT

  Patient problems: Cardiac Arrest; Death; Hypoxia; Low Blood Pressure/ Hypotension; Thrombosis

  MAUDE report 6617912 ↗
• InjuryMay 24, 2017Device Displays Incorrect Message

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. NOISE DISPLAYED ON THE DISTAL ELECTRODES OF THE THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER (CATHETER #1). THE CABLE WAS REPLACED AND ERROR 105 AND EEPROM DATA ERROR DISPLAYED ON THE CARTO 3 SYSTEM. THE CATHETER WAS EXCHANGED FOR A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER (CATHETER # 2), SINCE A REPLACEMENT THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER WAS NOT AVAILABLE. THE NOISE ISSUE AND ERRORS ARE NOT MDR REPORTABLE BECAUSE THE RISK TO THE PATIENT IS LOW. AFTER MAPPING WITH THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNSPECIFIED AMOUNT OF FLUID. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF COMPLAINT REPORT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR RECOVERY FROM SURG

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6589660 ↗
• InjuryApr 17, 2017Improper or Incorrect Procedure or Method

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT WITH 130 CONSECUTIVE PATIENTS WHO UNDERWENT CATHETER ABLATION OF IDIOPATHIC LEFT BUNDLE BLOCK MORPHOLOGY (DOMINANT S WAVE IN LEAD V1) OT-VAS BETWEEN JANUARY 2010 AND FEBRUARY 2015. AMONG THEM, 1 PATIENT IN THE PBV2 GROUP SUFFERED PERICARDIAL EFFUSION WITHOUT CARDIAC COMPRESSION AND TREATED WITH PERICARDIOCENTESIS. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. IT WAS REPORTED ONE (B)(6) FEMALE ((B)(6)) PATIENT IN THE PBV2 GROUP SUFFERED PERICARDIAL EFFUSION WITHOUT CARDIAC COMPRESSION AND TREATED WITH PERICARDIOCENTESIS. PATIENT REQUIRED ADDITIONAL ONE-DAY OBSERVATION AND FULLY RECOVERED. LOT # 16050905L THERMOCOOL SF NAV 7.5F DF CATHETER WAS USED IN THIS EVENT. THE AUTHOR STATED THAT BWI DEVICE POSSIBLY LED TO THE REPORTED PATIENT CONSEQUENCE, AND THE EVENT WAS PROCEDURE RELATED. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. TITLE: ¿OUTCOMES OF CATHETER ABLATION OF IDIOPATHIC OUTFLOW TRACT VENTRICULAR ARRHYTHMIAS WITH AN R WAVE PATTERN BREAK IN LEAD V2: A DISTINCT CLINICAL ENTITY¿ THE PURPOSE OF THIS STUDY WAS TO CHARACTERIZE THE ANATOMIC ORIGIN, ELECTROPHYSIOLOGICAL

  Patient problems: Pericardial Effusion

  MAUDE report 6498108 ↗
• InjuryApr 17, 2017Break

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT WITH 130 CONSECUTIVE PATIENTS WHO UNDERWENT CATHETER ABLATION OF IDIOPATHIC LEFT BUNDLE BLOCK MORPHOLOGY (DOMINANT S WAVE IN LEAD V1) OT-VAS BETWEEN JANUARY 2010 AND FEBRUARY 2015. AMONG THEM, 1 PATIENT IN THE REFERENCE GROUP SUFFERED PERICARDIAL EFFUSION WITHOUT CARDIAC COMPRESSION AND TREATED WITH PERICARDIOCENTESIS. ADDITIONAL INFORMATION WAS RECEIVED ON THIS EVENT. IT WAS REPORTED ONE (B)(6) FEMALE (90.7KG) PATIENT IN THE REFERENCE GROUP SUFFERED PERICARDIAL EFFUSION WITHOUT CARDIAC COMPRESSION AND TREATED WITH PERICARDIOCENTESIS. PATIENT REQUIRED ADDITIONAL ONE-DAY OBSERVATION AND FULLY RECOVERED. LOT # 17074613L THERMOCOOL SF NAV 7.5F D-F CURVE CATHETER WAS USED IN THIS EVENT. THE AUTHOR STATED THAT BWI DEVICE POSSIBLY LED TO THE REPORTED PATIENT CONSEQUENCE, AND THE EVENT WAS PROCEDURE RELATED. THE EVENT DID NOT RESULT IN THE IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. TITLE: ¿OUTCOMES OF CATHETER ABLATION OF IDIOPATHIC OUTFLOW TRACT VENTRICULAR ARRHYTHMIASWITH AN R WAVE PATTERN BREAK IN LEAD V2: A DISTINCT CLINICAL ENTITY¿ THE PURPOSE OF THIS STUDY WAS TO CHARACTERIZE THE ANATOMIC ORIGIN, ELEC

  Patient problems: Pericardial Effusion

  MAUDE report 6497983 ↗
• InjuryFeb 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA/RIGHT ATRIAL FLUTTER WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE ABLATION PHASE, A TAMPONADE WAS DETECTED. IT WAS NOTED THAT THE PHYSICIAN FELT AND HEARD A STEAM POP. A PERICARDIOCENTESIS WAS PERFORMED AND YIELDED 350CC OF FLUID. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT FOR OBSERVATION. PATIENT REQUIRED ONE DAY OF EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT FOR OBSERVATION. PATIENT FULLY RECOVERED. THERE WERE NO FACTORS CITED THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE STEAM POP. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. SHEATH IN USE WAS AN 8 FRENCH, BRAND UNSPECIFIED. GENERATOR SETTINGS AT THE TIME OF INJURY INCLUDED POWER CONTROL MODE AT 40 WATTS (NOT TITRATED), TEMPERATURE OF APPROXIMATELY 30°C, AND IMPEDANCE IN THE 120S (OHMS). OVERALL ABLATION TIME AT THE SITE OF INJURY (CAVOTRICUSPID ISTHMUS) WAS APPROXIMATELY 5 MINUTES. LAST

  Patient problems: Cardiac Tamponade

  MAUDE report 6360660 ↗
• MalfunctionFeb 6, 2017Over-Sensing

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A NOISE ISSUE OCCURRED. NOISE FROM ALL BODY SURFACE AND ALL INTRACARDIAC CHANNELS WAS BEING DISPLAYED ON THE CARTO 3 SYSTEM AND ON THE RECORDING SYSTEM. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE THIS EVENT IS MDR REPORTABLE BECAUSE THE INABILITY TO MONITOR THE PATIENT¿S ECG RHYTHM WHILE DEVICES ARE INTRA CARDIAC MIGHT LEAD TO UNDETECTED CARDIAC RHYTHM THAT COULD BE LIFE THREATENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306198 ↗
• DeathJan 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT IN HIS 70S UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SOUNDSTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PHARMACOLOGIC SUPPORT) WHICH RESULTED IN DEATH. DURING ABLATION PHASE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND EXPIRED THE SAME DAY. CARDIOVASCULAR MEDICAL HISTORY INCLUDES: ISCHEMIC CARDIOMYOPATHY WITH LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 15%, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND TOTAL OCCLUSION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH STENTS IN THE LEFT CIRCUMFLEX (LCX) AND THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERIES. THERE WERE NO OTHER FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT MAY HAVE BEEN RELATED TO THE SOUNDSTAR CATHETER BEING IN THE RIGHT ATRIUM DURING CARDIOVERSION OF VENTRICULAR TACHYCARDIA (8 SHOCKS). TRANSSEPTAL PUNCTURE WAS NOT PERFORMED, AS THE PHYSI

  Patient problems: Cardiac Tamponade; Death; Low Blood Pressure/ Hypotension

  MAUDE report 6233883 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SIDED VENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIOCENTESIS AND SURGICAL REPAIR. THE PATIENT DEVELOPED A SMALL PERICARDIAL EFFUSION THAT OCCURRED DURING INTUBATION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH MORE THAN 500CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT REMAINED STABLE AND WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL REPAIR, FOLLOWED BY OBSERVATION IN THE CORONARY CARE UNIT. THE PHYSICIAN DID NOT PROVIDE A CASUALTY OPINION FOR THIS EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION IN THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 6215579 ↗
• DeathDec 7, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND WENT INTO VENTRICULAR FIBRILLATION AND DECEASED. AFTER ABLATION, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND COULD NOT BE CONVERTED INTO SINUS RHYTHM. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND EXTERNAL AND INTERNAL DEFIBRILLATION WAS DONE. IN ADDITION, AN IMPELLA LEFT VENTRICULAR ASSIST DEVICE WAS INSERTED WITH NO RESOLUTION. THE PATIENT THEN DECEASED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Death; Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 6151953 ↗
• InjuryDec 5, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING MAPPING, THE PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC. THE CARDIAC TAMPONADE WAS CONFIRMED VIA TRANSTHORACIC ECHOCARDIOGRAM. THE PERICARDIOCENTESIS YIELDED 225CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. THE PATIENT OUTCOME IS IMPROVED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT OCCURRED DURING THE MAPPING PHASE AND THAT THERE WAS NO INDICATION THAT THE CATHETER MALFUNCTIONED. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE WAS NO SHEATH INFORMATION. GENERATOR PARAMETERS WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED. THERE WAS NO INFORMATION REGARDING THE IRRIGATED CATHETER FLOW SETTING. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME GOAL OF 250-300 SECONDS. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BIOSENSE WEBST

  Patient problems: Cardiac Tamponade

  MAUDE report 6146620 ↗
• InjuryOct 12, 2016Use of Device Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR SYMPTOMATIC PERSISTENT ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A PERICARDIAL EFFUSION REQUIRING EXTENDED HOSPITALIZATION. ON THE DAY OF THE PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. THE ISSUE RESOLVED WITHOUT SEQUELAE. MEDICAL HISTORY INCLUDES HYPERTENSION, ASCENDING AORTA MILD DILATATION, ATRIAL FLUTTER, AND SINUS BRADYCARDIA. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT TO BE MILD IN SEVERITY, SERIOUS, POSSIBLY DEVICE-RELATED, AND DEFINITELY PROCEDURE-RELATED. SINCE THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THIS EVENT, IT IS MDR REPORTABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 6024452 ↗