ThermoCool SF NAV BNI35BDHRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10846835003154), received between Dec 30, 2016 and Jul 17, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR TACHYCARDIA ABLATION WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER ABLATION (FIRST TIME AND DURING FIRST SESSION) WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER, THE PATIENT'S BLOOD PRESSURE DECREASED. ABLATION WAS PERFORMED PRIOR TO PERICARDIAL EFFUSION WAS CONFIRMED. PERICARDIAL DRAINAGE WAS PERFORMED, AND THE PATIENT'S BLOOD PRESSURE NORMALIZED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ABLATION. THE PATIENT HAS FULLY RECOVERED AND DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE, HOWEVER IT IS STILL UNKNOWN WHEN THE CARDIAC TAMPONADE OCCURRED. ATRIAL SEPTAL PUNCTURE WAS NOT PERFORMED. STEAM POP WAS NOT CONFIRMED. NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT.

  Patient problems: Cardiac Tamponade

  MAUDE report 19766414 ↗
• InjuryJun 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS LOOKING FOR TARGET SITE, CARDIAC TAMPONADE WAS FOUND TO HAVE OCCURRED. AFTER CARDIAC TAMPONADE WAS FOUND TO HAVE OCCURRED, IT WAS CONFIRMED WHETHER PERICARDIAL EFFUSION WAS ACCUMULATED BY ECHOCARDIOGRAPHY, AND PERICARDIAL DRAINAGE WAS PERFORMED. AFTER THAT, BLOOD PRESSURE RESTORED TO AROUND 100-110. THE PATIENT RETURNED TO ROOM WITH ELECTROCARDIOGRAM MONITOR ON. PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PHYSICIAN COMMENTED AFTER THE PROCEDURE THAT THERE WAS NO CAUSAL RELATIONSHIP WITH THE PRODUCT. ABLATION WAS PERFORMED PRIOR TO NOTING THE EFFUSION. THE EFFUSION OCCURRED AFTER PSVT WAS ABLATED AND RECURRENCE WAS CONFIRMED, WHEN THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WAS RE-INSERTED. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED. NO EVIDENCE OF STEAM POP. PATIENT HAS IMPROVED.

  Patient problems: Cardiac Tamponade

  MAUDE report 19620443 ↗
• InjuryNov 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A 47-YEAR-OLD MALE PATIENT WEIGHING 47.0 KG UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A THERMOCOOL®SF NAV BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. POP OCCURRED WHILE CONDUCTING ABLATION OF THE RVOT IN PVC PROCEDURE. PERICARDIAL EFFUSION WAS CONFIRMED BY ECHOCARDIOGRAPHY. TIMING WHEN COMPLAINTS OCCURRED WAS AFTER APPROXIMATELY 1 HOUR AFTER THE START OF THE PROCEDURE. DURING 11TH ABLATION. BLOOD PRESSURE RETURNED AFTER DRAINAGE, AND THE PATIENT LEFT FROM THE ROOM. THE PROCEDURE WAS TERMINATED. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS NONE. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO USE AND DURING USE OF THE PRODUCT. [RELEVANT MEDICAL HISTORY]: UNKNOWN. [RELEVANT TESTS/LABORATORY DATA]: PVC DID NOT DISAPPEAR, AND THE PROCEDURE WAS TERMINATED. PROCEDURE: PREMATURE VENTRICULAR CONTRACTION. ABLATION WAS PERFORMED PRIOR TO NOTING THE PE OR CT. NO ERROR MESSAGE OBSERVED DURING THE PROCEDURE. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THE CAUSE WAS UNKNOWN. OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN. THEY TRIED TO OBTAIN DETAILED INFORMATI

  Patient problems: Cardiac Tamponade

  MAUDE report 15854381 ↗
• InjuryJul 13, 2022Device Contamination with Body Fluid; High Readings; Patient Device Interaction Problem; Device Contamination with Body Fluid; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH TWO THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETERS (2) AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PVC PROCEDURE, THE CATHETER WAS ADVANCED TO THE TARGET SITE RIGHT VENTRICLE (RV), IMPEDANCE WAS SHOWN AS ABOUT 200 OHM. THEY EXCHANGED TO A NEW CABLE BUT THERE IS NO CHANGE ON THE IMPEDANCE, AND THEN, THE CATHETER WAS REPLACED WITH A NEW CATHETER OF THE SAME TYPE BUT THE VALUE DID NOT CHANGE. THEREFORE, WHEN THE CATHETER WAS MOVED TO ANOTHER POSITION, THE VALUE WAS AROUND 130 ~ 180 OHM. FIRST ABLATION WAS CONDUCTED AS 30W/5SEC AND IMPEDANCE WAS 53 OHM DOWN FROM THE STARTING OF 234 OHM. THE SECOND ABLATION WAS CONDUCTED AT 30W/5SEC AND IMPEDANCE WAS 52 DOWN FROM THE STARTING OF 204 OHM. AFTER SWITCHING TO LIFELINE ABLAZE, DECREASED BLOOD PRESSURE WAS CONFIRMED. THEN, SETTING WAS SET AT 50 W WITH ABLAZE (W WAS CHANGED AT 1 ~ 40 W) AND ABLATION WAS STARTED AT 135 OHM (MAX 152 OHM), 27 SECONDS ABLATION WAS PERFORMED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO, AND DRAINAGE WAS STARTED. ECHO WAS CONFIRMED AGAIN, BLOOD PRESSURE RETURNED TO NORMAL LIMITS, AND

  Patient problems: Cardiac Tamponade

  MAUDE report 15009420 ↗
• InjuryJul 13, 2022Device Contamination with Body Fluid; High Readings; Patient Device Interaction Problem; Device Contamination with Body Fluid; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH TWO THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETERS (2) AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PVC PROCEDURE, THE CATHETER WAS ADVANCED TO THE TARGET SITE RIGHT VENTRICLE (RV), IMPEDANCE WAS SHOWN AS ABOUT 200 OHM. THEY EXCHANGED TO A NEW CABLE BUT THERE IS NO CHANGE ON THE IMPEDANCE, AND THEN, THE CATHETER WAS REPLACED WITH A NEW CATHETER OF THE SAME TYPE BUT THE VALUE DID NOT CHANGE. THEREFORE, WHEN THE CATHETER WAS MOVED TO ANOTHER POSITION, THE VALUE WAS AROUND 130 ~ 180 OHM. FIRST ABLATION WAS CONDUCTED AS 30W/5SEC AND IMPEDANCE WAS 53 OHM DOWN FROM THE STARTING OF 234 OHM. THE SECOND ABLATION WAS CONDUCTED AT 30W/5SEC AND IMPEDANCE WAS 52 DOWN FROM THE STARTING OF 204 OHM. AFTER SWITCHING TO LIFELINE ABLAZE, DECREASED BLOOD PRESSURE WAS CONFIRMED. THEN, SETTING WAS SET AT 50 W WITH ABLAZE (W WAS CHANGED AT 1 ~ 40 W) AND ABLATION WAS STARTED AT 135 OHM (MAX 152 OHM), 27 SECONDS ABLATION WAS PERFORMED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO, AND DRAINAGE WAS STARTED. ECHO WAS CONFIRMED AGAIN, BLOOD PRESSURE RETURNED TO NORMAL LIMITS, AND

  Patient problems: Cardiac Tamponade

  MAUDE report 15009315 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE PATIENT¿S BLOOD PRESSURE DECREASED JUST BEFORE ABLATION. THE THERMOCOOL WAS INTRODUCED ON PATIENT AT THE TIME OF HYPOTENSION. BECAUSE THE PATIENT WAS A CHILD, THE CHEST WAS IMMEDIATELY OPENED AND TREATED. AT THAT TIME, IT WAS FOUND TO BE TAMPONADE ON THE UNKNOWN DIAGNOSTIC CATHETER; NOT AN ABLATION CATHETER. THE PHYSICIAN COMMENTED THAT SINCE IT IS A DIAGNOSTIC CATHETER, THERE IS NO RELATIONSHIP WITH THE PRODUCT. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE WAS NOT RELATED WITH THE PRODUCT. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS). THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AND FOLLOW-UP WAS REQUIRED IN THE CARDIAC CARE UNIT (CCU) DUE TO THE OUTCOME OF THE ADVERSE EVENT. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A NON-J&J PRODUCT (SPECIFIC PRODUCT DETAILS NOT PROVIDED). THE EVENT OCCURRED PRE-ABLATION., HOWEVER THIS EVENT WILL BE CONSERVATIVELY REPORTED AGAINST THE BWI ABLATION CATHETER SINCE IT WAS IN THE

  Patient problems: Cardiac Tamponade

  MAUDE report 13982031 ↗
• InjuryApr 23, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER THE CATHETER WAS INSERTED, MAPPING OF THE RIGHT VENTRICLE OUTFLOW TRACT (RVOT) WAS PERFORMED. AFTER THAT, CARDIAC TAMPONADE WAS DIAGNOSED AND PERICARDIOCENTESIS WAS DONE TO DRAIN THE FLUID. PATIENT¿S VITALS THEN BECAME STABLE, AND THE ABLATION PROCEDURE COULD BE SAFELY FINISHED. NO ABLATION HAD BEEN CONDUCTED BEFORE THE CARDIAC TAMPONADE OCCURRED. THE PATIENT WAS FOLLOWED UP AFTER THE PROCEDURE. THERE¿S NO REPORT OF PROLONGED HOSPITALIZATION. PATIENT¿S CONDITION IMPROVED. THE PHYSICIAN DOES NOT KNOW WHAT THE CAUSE OF THE ISSUE WAS BUT COMMENTED IT WAS NOT RELATED TO THE BWI PRODUCT. NO BWI PRODUCT MALFUNCTION WAS REPORTED.

  Patient problems: Cardiac Tamponade

  MAUDE report 11713945 ↗
• InjuryDec 22, 2020High Readings; Patient Device Interaction Problem; High Readings; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR ABLATION PROCEDURE WITH RIGHT VENTRICLE OUTFLOW (RVOT) ORIGIN WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE IMPEDANCE ROSE OVER 400 OHMS WHEN THE CATHETER WAS MOVED TO THE PULMONARY ARTERY. AFTER PERFORMED 3 ABLATIONS, A DECREASE IN THE PATIENT¿S BLOOD PRESSURE WAS NOTICED. CARDIAC TAMPONADE WAS CONFIRMED BY ECHOCARDIOGRAPHY, AND PERICARDIOCENTESIS WAS PERFORMED TO DRAIN VENOUS BLOOD FROM THE PERICARDIAL SPACE. NORADRENALINE WAS ADMINISTERED AND THE PATIENT HAD NO SERIOUS SYMPTOMS. BLOOD PRESSURE WAS RESTORED. PHYSICIAN BELIEVES THE PERFORATION MIGHT HAVE OCCURRED DURING CATHETER MANIPULATION IN THE VENTRICLE, PHYSICIAN STATED HE FELT RESISTANCE WHILE ADVANCING THE CATHETER; HOWEVER, DID NOT ATTRIBUTE THE CAUSALITY OF THE EVENT TO A BWI PRODUCT MALFUNCTION. PATIENT HAD RECOVERED FROM THE ISSUE. THERE¿S NO INDICATION THAT PROLONGED HOSPITALIZATION WAS REQUIRED. THE REPORTED ISSUE OF HIGH IMPEDANCE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THERE IS NO INDICATION THAT THE USER-DEFINED CUT-OFF WAS EXCEEDED THE POTENTIAL THAT IT COULD CAUSE

  Patient problems: Cardiac Tamponade

  MAUDE report 11060589 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND DEVELOPED VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VFIB) REQUIRING EXTERNAL DIRECT-CURRENT (DC) CARDIOVERSION. DURING ABLATION OF THE RIGHT VENTRICLE OUTFLOW TRACT (RVOT), THE PATIENT DEVELOPED VT/VFIB. EXTERNAL DC CARDIOVERSION WAS APPLIED AND RETURNED TO SINUS RHYTHM. TREATMENT CONTINUED AND PATIENT¿S HEMODYNAMICS WAS STABLE UPON LEAVING THE ROOM. THERE¿S NO INDICATION THAT EXTENDED HOSPITALIZATION WAS REQUIRED. PHYSICIAN COMMENTED THAT THE CAUSAL RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE BIOSENSE WEBSTER (BWI) PRODUCT IS UNLIKELY. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS NOR ERROR MESSAGES WERE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Ventricular Fibrillation; Ventricular Tachycardia

  MAUDE report 10458301 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS) AND VESSEL PERFORATION. DURING THE PROCEDURE, ONE (1) HOUR AFTER THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER HAD BEEN IN USE, IT WAS PLACED IN THE RIGHT VENTRICLE OUTFLOW TRACT (RVOT). IT WAS THEN NOTICED THE PATIENT¿S BLOOD PRESSURE DROPPED TO 40 UNITS. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION RELATED. THE PHYSICIAN COMMENTED THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE BIOSENSE WEBSTER INC. (BWI) PRODUCT AND THE ADVERSE EVENT. IT WAS ALSO REPORTED THAT WHILE USING THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER IN THE RVOT, THE IMPEDANCE ROSE TO 300 OHMS AND THERE¿S A POSSIBILITY THAT THE PULMONARY ARTERY (PA) WAS RUPTURED AT THAT TIME. THERE IS NO INFORMATION ABOUT MEDICAL/SURGICAL INTERVENTION FOR THE

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 8609545 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) ARISING FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER FAST ANATOMICAL MAP (FAM) GEOMETRY OF THE RVOT WAS CREATED, THE SEPTAL SIDE OF THE RVOT WAS ABLATED REPEATEDLY USING 30-35 WATTS. AORTIC CUSP GEOMETRY WAS CREATED VIA SOUNDSTAR ECO CATHETER AND ABLATION WAS PERFORMED USING 20-30 WATTS. SEPTAL SIDE OF THE RVOT WAS ABLATED AGAIN USING 30-35 WATTS. AT THE END OF THE PROCEDURE, A TAMPONADE WAS CONFIRMED VIA SOUNDSTAR ECO CATHETER. PERICARDIOCENTESIS YIELDED 500 ML. POST-PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME IS IMPROVED. IT WAS NOTED THAT DURING THE PROCEDURE, THERE WERE NO SIGNIFICANT CHANGES IN BLOOD PRESSURE, HEART RATE, OR IMPEDANCE. IT WAS NOTED THAT THE ADVERSE EVENT MAY HAVE OCCURRED DURING MAPPING OR ABLATION PHASE. PHYSICIAN INDICATED THAT THERE WERE AN EXCESSIVE NUMBER OF ABLATIONS. THERE WERE NO ADDITIONAL FACTORS CITED THAT MAY HAVE CONTRIBUTE

  Patient problems: Cardiac Tamponade

  MAUDE report 6673788 ↗
• InjuryDec 30, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATYPICAL ATRIAL FLUTTER WITH A THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER AND THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED AN ACUTE MYOCARDIAL INFARCTION (AMI) REQUIRING PACING AND CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND PHARMACOLOGIC SUPPORT. DURING ABLATION, ST ELEVATION WAS NOTED IN THE INFERIOR LEADS (II, III, AND AVF). PATIENT WAS PACED VIA THE ABLATION CATHETER IN THE RIGHT VENTRICULAR APEX. PATIENT WENT INTO CARDIAC ARREST AND CPR WAS INITIATED AND PHARMACOLOGIC SUPPORT WAS PROVIDED. CORONARY ANGIOGRAM REVEALED NO PATHOLOGY. PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. IT WAS NOTED THAT THE PATIENT REMAINED IN ATRIAL FLUTTER THROUGHOUT THE PROCEDURE. THE FLUTTER WAS UNALTERED BY THE EVENT OR BY THE ABLATION PROCEDURE AT THAT TIME. IT WAS ALSO NOTED THAT THE PATIENT LATER RETURNED TO SINUS RHYTHM. PATIENT HAS A HISTORY OF PRIOR PULMONARY VEIN ISOLATION (PVI) ABLATION. PHYSICIAN IS UNCERTAIN REGARDING THE CAUSE OF THE ADVERSE EVENT. PHYSICIAN CONFIRMED THAT THE ADVERSE EVENT WAS NOT CAUSED BY BWI

  Patient problems: ST Segment Elevation

  MAUDE report 6215543 ↗