ThermoCool SF NAV BNI35BFHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835003178), received between Feb 8, 2017 and Apr 4, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING MAPPING PHASE, CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿ OUTCOME IS IMPROVED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS UNKNOWN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. NO ABLATION OCCURRED PRIOR TO THE ADVERSE EVENT. THE CATHETER IRRIGATION WAS SET AT 2 ML/MIN IN LOW FLOW.

  Patient problems: Cardiac Tamponade

  MAUDE report 8483866 ↗
• MalfunctionJun 14, 2018Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AFIB ¿ PAROXYSMAL PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND THROMBUS/CHAR ISSUE OCCURRED. THE PHYSICIAN REPORTED THROMBUS OR CHARRING WAS OBSERVED AT THE CATHETER ELECTRODE WHEN THE PROCEDURE WAS FINISHED. THE THROMBUS/CLOT WAS SUSPECTED TO BE COAGULUM AND THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE COMPLETED. THE PHYSICIAN ALSO REPORTED POOR SIGNAL QUALITY DURING THE CASE AND SUSPECTED THAT THERE MIGHT HAVE BEEN AN ISSUE WITH THE INSULATION OF THE CATHETER. HOWEVER, IT WAS LATER CLARIFIED THAT NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE OF COAGULUM IS CONSIDERED A REPORTABLE MALFUNCTION, HOWEVER, THE ISSUE OF POOR SIGNAL QUALITY IS NOT A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600634 ↗
• DeathFeb 8, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION) AND DEATH. DURING THE SECOND TRANSSEPTAL PUNCTURE, THE PATIENT BECAME HYPOTENSIVE AND A TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS YIELDED A LARGE AMOUNT OF FLUID (UNSPECIFIED). PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IMMEDIATELY AFTER THE EVENT. THERE IS NO INFORMATION REGARDING THE LENGTH OF HOSPITALIZATION. PATIENT CONDITION WORSENED, AS THEY WERE TRANSFERRED TO A DIFFERENT FACILITY FOR A SURGICAL INTERVENTION AND EXPIRED IN THE HOSPITAL. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE SECOND TRANSSEPTAL PUNCTURE, AND NOT RELATED TO THE ABLATION CATHETER. SHEATH IN USE WAS A ST. JUDE MEDICAL S1. GENERATOR PARAMETERS WERE NOT REPORTED, AS NO ABLATION WAS PERFORMED. IT WAS REPORTED THAT THE INJURY OCCURRED AS A RESULT OF TRANSSEPTAL PUNCTURE AND WAS DETECTED IMMEDIATELY. IRRIGATED CATHETER FLOW WAS SET AT 2ML/MIN. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH A S

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

  MAUDE report 6313314 ↗