ThermoCool SF NAV BNI35FJCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10846835003260), received between Jun 15, 2016 and Apr 12, 2023 — classified as 1 death, 9 injuries, 1 malfunction.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• DeathApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION BUT ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION (PE). THEY STATED THAT AFTER CRYO ABLATION THERE WAS SOME RF ABLATION WAS PERFORMED, AND THE PATIENT SPONTANEOUSLY CONVERTED FROM ATRIAL FIBRILLATION TO SINUS AFTER THE RF ABLATION. THE PRESSURE DROPPED AND WHEN THE PHYSICIAN LOOKED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THEY OBSERVED A PERICARDIAL EFFUSION. THE LOCATION OF THE EFFUSION WAS UNKNOWN. A PERICARDIOCENTESIS WAS PERFORMED AND 630 ML WAS REMOVED. THEY CONFIRMED THAT THE DRAINAGE TUBE WAS LEFT IN PLACE. THE PATIENT'S PROGNOSIS WAS STABILIZED AND HAS IMPROVED. THE PATIENT WILL BE ADMITTED TO THE INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION. THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. IT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE PHYSICIAN SUSPECTED A STEAM POP. INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND CARDIOV

  Patient problems: Cardiac Tamponade

  MAUDE report 16729160 ↗
• InjurySep 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 55-YEAR-OLD MALE PATIENT BORN ON (B)(6) 1947, UNDERWENT A LEFT ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT - LEFT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. TOWARDS THE END OF THE CASE THE PATIENTS¿ BLOOD PRESSURE DROPPED. THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER WAS USED TO CONFIRM A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND ABOUT 2 LITERS OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE AND TRANSFUSED BACK INTO THE PATIENT. THE PATIENT STABILIZED FOR A TIME, BUT THE PRESSURE DROPPED AGAIN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR). CALLER STATED THAT A MAX OF 30 WATTS WAS USED DURING THE PROCEDURE AND TOTAL ABLATION TIME WAS 20 MIN 16 SECONDS. CATHETER IRRIGATION WAS RUN PER THE CATHETER INSTRUCTION FOR USE (IFU) GUIDELINES. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE CALL. ADDITIONAL INFORMATION RECEIVED INDICATED THE BWI REPRESENTATIVE CONSULTANT DIDN¿T GET THE PHYSICIAN OPINION POST PROCEDURE SINCE T

  Patient problems: Cardiac Tamponade

  MAUDE report 15480705 ↗
• InjuryOct 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PATIENT HAD A CARDIAC EFFUSION. THE EFFUSION WAS VERIFIED VIA ICE. THE PATIENT HAD LOW BLOOD PRESSURE. THE PATIENT HAD A PERICARDIOCENTESIS AND 700 CCS OF FLUID WERE REMOVED. THE DRAIN WAS KEPT IN PLACE AND THE PATIENT DID NOT REQUIRE ANY SURGICAL REPAIR. THE PATIENT IS STABLE AND IS STAYING OVERNIGHT FOR OBSERVATION. THE PHYSICIAN STATED THEY ARE UNSURE OF WHEN THE EFFUSION OCCURRED. THEY WERE USING 40 WATTS DURING THE ABLATION. SINCE THE EVENT IS LIFE THREATENING AND REQUIRED CANCELLATION OF THE PROCEDURE TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 12696011 ↗
• InjuryNov 20, 2019Adverse 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 AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER MAPPING AND ABLATING FROM THE RETROGRADE AORTIC APPROACH, THE PHYSICIAN OBTAINED TRANSSEPTAL ACCESS TO CONTINUE. AT THE END OF THE PROCEDURE, A DROP IN BLOOD PRESSURE WAS NOTICED. CARDIAC TAMPONADE WAS CONFIRMED USING INTRACARDIAC ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 220 CC OF FLUID FROM AROUND THE PATIENT'S HEART. PATIENT WAS LEFT WITH A DRAIN IN PLACE. THE PATIENT'S BLOOD PRESSURE STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT CONDITION IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY FOR THE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THE FLOW SETTING WAS SET TO STANDARD SETTINGS. THERE WAS NO EVIDENCE OF STEAM POP DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 9345866 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A (B)(6)-YEAR-OLD-FEMALE PATIENT UNDERWENT A RIGHT IDIOPATHIC VENTRICULAR FIBRILLATION (IDVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED BY THE CALLER THAT AT THE END OF THE ABLATION PROCEDURE AFTER THE CATHETERS WERE REMOVED THE PATIENT¿S BLOOD PRESSURE DROPPED. A TRANS-THORACIC ECHO WAS PERFORMED AND IS WAS OBSERVED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED IN WHICH 300 CC'S WAS REMOVED FROM THE PERICARDIAL SPACE. THE DRAIN WAS LEFT IN PLACE AND THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR OBSERVATION. ON 10/07/2019, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT AND PATIENT. THE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN IS UNSURE ON THE CAUSE OF THIS ADVERSE EVENT. THE PATIENT OUTCOME IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT REQUIRED ADDITIONAL HOSPITALIZATION. THE PATIENT WAS A 74 Y/O FEMALE. IT IS UNKNOWN IF TRANSSEPTAL WAS PERFORMED OR THE NEEDLE BRAND/MODEL THAT WAS USED. THE EVENT OCCURRED AFTER ABLATION WAS PERFORMED

  Patient problems: Cardiac Tamponade

  MAUDE report 9233170 ↗
• MalfunctionOct 11, 2019Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND ELECTRODE DAMAGES. INITIALLY IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, DURING THE MAPPING PHASE OF THE PROCEDURE THE DEFLECTION MECHANISM OF THE CATHETER DID NOT WORK PROPERLY. CATHETER REPLACEMENT RESOLVED THE ISSUE. SURGERY WAS NOT DELAYED AND NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED DEFLECTION ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 9/25/2019, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, THE DISTAL TIP WAS OBSERVED BENT. FURTHER TESTING WAS THEN PERFORMED. DURING A SECOND VISUAL INSPECTION ON 10/2/2019, THE BWI PAL OBSERVED A KINK IN THE PEEK HOUSING, ELECTRODE DAMAGE, AND SHARP EDGES. THE OBSERVED BENT DISTAL TIP AND KINKED PEEK HOUSING HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE FINDINGS OF ELECTRODE DAMAGE WITH SHARP EDGES HAS BEEN A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180618 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE, THERE WAS A DROP-IN PATIENT¿S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO. ALL CATHETERS WERE REMOVED FROM PATIENT¿S BODY. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 550 CC OF FLUID FROM THE PERICARDIUM. OF THAT, 450 CC WERE AUTO-TRANSFUSED BACK INTO THE PATIENT. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PHYSICIAN WAS UNSURE WHEN OR HOW THE PERFORATION OCCURRED, BUT STATED IT WAS POSSIBLE. IT OCCURRED DURING THE CARDIOVERSION. 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 8217733 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE, CARDIAC TAMPONADE WAS DISCOVERED BY ULTRASOUND AND CONFIRMED BY INTRACARDIAC ECHO (ICE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) AND REMAINED THERE ONE WEEK AFTER THE PROCEDURE. PATIENT¿S OUTCOME IS IMPROVED. RETROGRADE APPROACH TO THE LEFT VENTRICLE WAS CITED AS A FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. THERE¿S NO INFORMATION REGARDING PHYSICIAN¿S CAUSALITY OPINION. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. THE GENERATOR WAS SET UNDER THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER DEFAULT SETTINGS AT 30 WATTS AND 60 SECONDS. ABLATION DID NOT OCCUR PRIOR TO THE ADVERSE EVENT. THE CATHETER IRRIGATION WAS SET AT 8-15ML/MIN AND 2ML/MIN IN LOW FLOW. THE PATIE

  Patient problems: Cardiac Tamponade

  MAUDE report 8033138 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING POST-ABLATION PACING, THE ANESTHESIOLOGIST NOTED AND MENTIONED TO THE PHYSICIAN A DROP IN THE PATIENT'S BLOOD PRESSURE. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 300 CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME OR PHYSICIAN CAUSALITY OPINION. THERE WERE NO BIOSENSE WEBSTER, INC. PRODUCT ISSUES REPORTED DURING THE PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: Cardiac Tamponade

  MAUDE report 8021965 ↗
• InjuryJun 16, 2016Device Displays Incorrect Message; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE FOR AN IDIOPATHIC VENTRICULAR TACHYCARDIA WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. AFTER WAITING 10 MINUTES AFTER THE LAST ABLATION, THE PHYSICIAN WANTED TO USE THE INTRACARDIAC ULTRASOUND WITH THE EXISTING SOUNDSTAR ECO CATHETER TO SCAN THE HEART FOR AN EFFUSION AS A ROUTINE SCAN. THE PATIENT WAS NOT SYMPTOMATIC. PERICARDIAL FLUID WAS SEEN AT THAT TIME. THE PATIENT WAS SEDATED FURTHER FOR INTERVENTION. THE PERICARDIOCENTESIS YIELDED 130CC. A DRAIN WAS LEFT IN PLACE. THE PATIENT TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION DUE TO THE DRAIN WHICH WAS PLACED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME OF REPORT. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THERE WAS NO ISSUE NOTED WITH THE CATHETER. THERE WERE NO ERROR MESSAGES AT THE TIME OF THE EVENT. HOWEVER, INITIALLY A, "TEMP LIMITER" ERROR CAME ON THE STOCKERT GENERATOR WITH THE FIRST ABLATION ATTEMPT. A REPROCESSED CABLE WAS USED AND THAT WAS IMMEDIATELY SWITCHED FO

  Patient problems: Cardiac Tamponade

  MAUDE report 5730895 ↗
• InjuryJun 15, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR A RIGHT ATRIAL FLUTTER WITH AN EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. DURING THE ABLATION PHASE, AT THE MIDDLE STAGE OF THE PROCEDURE, A STEAM POP WAS NOTICED BY THE PHYSICIAN. THE PHYSICIAN DID NOT BELIEVE THERE WAS ANY INJURY AT THIS TIME. THE CARDIAC TAMPONADE WAS NOTICED AFTER THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED WHICH YIELDED 300CC OF FLUID. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. 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 WAS PROCEDURE-RELATED. THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH AN UNKNOWN NEEDLE. THERE IS NO INFORMATION REGARDING THE SHEATH USED. THE GENERATOR WAS SET TO POWER CONTROL MODE AT 40 WATTS AND WAS NOT TITRATED. THE TEMPERATURE CUT-OFF WAS SET TO 80 CELSIUS. THE IMPEDANCE CUT-OFF WAS SET AT 250 OHMS. THERE IS NO INFORMATION REGARDING OVE

  Patient problems: Cardiac Tamponade

  MAUDE report 5728277 ↗