ThermoCool SF NAV BNI35DDHRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835003192), received between Oct 23, 2018 and Jul 30, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTICULAR CONTRACTION (PVC) CARDIAC ABLATION WITH A VIZIGO SHEATH AND THERMOCOOL SF NAV CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. TWO HOURS AFTER THE START OF THE PROCEDURE, AFTER ABLATING IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR PVC PROCEDURE, DURING RE-MAPPING, THE HEARTBEAT WAS WEAKENED IN CINE. CARDIAC TAMPONADE WAS SUSPECTED AND DRAINAGE WAS PERFORMED. THE PROCEDURE WAS COMPLETED AS IT WAS. THE PHYSICIAN'S OPINIONS ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT IS THAT THERE WAS NO FORCEFUL MANIPULATION OR EXCESSIVE ABLATION DURING MAPPING OR ABLATING, BUT BASED ON THE TIMING OF NOTICING THE TAMPONADE, THERE IS A POSSIBILITY THAT SOMETHING WAS CAUGHT BY THE ABLATION CATHETER OR THE SHEATH. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. ABLATION WAS PERFORMED PRIOR TO IDENTIFYING THE TAMPONADE. NO STEAM POPS WERE CONFIRMED. NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS

  Patient problems: Cardiac Tamponade

  MAUDE report 19869183 ↗
• InjuryJun 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT 2 ISSUES OCCURRED; COULD NOT CONDUCT THE ABLATION DUE TO AN ¿IMPEDANCE TOO HIGH¿ ERROR. BLOOD PRESSURE DROPPED DURING THE SECOND ABLATION AT RVOT. ECHOCARDIOGRAPHY CONFIRMED PERICARDIAL EFFUSION, AND DRAINAGE WAS PERFORMED. HEMOSTATIC AGENT WAS USED TO STOP BLEEDING AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE ENDED WITH INSUFFICIENT TREATMENT. TIMING WAS WHEN; WHEN CATHETER WAS INSERTED INTO THE INTRACARDIAC AFTER MAPPING AND DC. THE ABLATION CATHETER WAS EXTRACARDIAC DURING DC. BODY SURFACE DC WAS USED. 2 HOURS AFTER THE START OF TREATMENT. DURING ABLATION. PROCEDURE WAS COMPLETED BY ; RESTARTED THE SYSTEM AND CONTINUED THE PROCEDURE. DRAINAGE. CARDIAC TAMPONADE ABLATION WAS PERFORMED BEFORE PERICARDIAL EFFUSION OR TAMPONADE WAS IDENTIFIED. STEAM POP WAS NOT OBSERVED. IRRIGATION CATHETER¿S FLOW RATE SETTING WAS LOW 8ML, HIGH 15ML. THE ABLATION WAS CONDUCTED AT 30 W FOR 60 SECONDS, AND THE VISITAG WAS DISPLAYED AS TOTAL TIME BECAUSE THE CATHETER HAD NO C

  Patient problems: Cardiac Tamponade

  MAUDE report 17071989 ↗
• InjuryJul 17, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT (162 CM, (B)(6) KG) UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED COMPLETE HEART BLOCK REQUIRING PROLONGED HOSPITALIZATION. ABLATION WAS CONDUCTED IN THE EARLIEST SITE OF THE PVC AT 35 W FOR 60 SECONDS. AFTER ABLATION, COMPLETE AV (ATRIOVENTRICULAR) BLOCK WAS FOUND AND WHEN THE ELECTRICAL SIGNAL WAS RECHECKED, AV BLOCK OCCURRED AFTER ABLATION WAS CONDUCTED 38 SECONDS. FORTUNATELY, VENTRICULAR ESCAPE RHYTHM WAS ABOUT 60 BPM, SO NO URGENT MEASURES WERE TAKEN. THE TEAM WAITED A WHILE, BUT A NORMAL RHYTHM WAS NOT COMING BACK. ISOPROTERENOL WAS ADMINISTERED INTRAVENOUSLY, AND THE HEART RATE RECOVERED TO 2: 1 AV BLOCK. HOWEVER, WHEN THE EFFECT OF ISOPROTERENOL EXPIRED, IT RETURNED TO COMPLETE AV BLOCK. IT LOOKED BACK THE ELECTRICAL SIGNAL OF THE ABLATION CATHETER BEFORE ABLATION AND NOTICED THAT HIS ELECTRICAL SIGNAL WAS SAW WHEN INCREASING THE MAGNIFICATION. THE EVENT OCCURRED DURING LEFT VENTRICLE (LV) SEPTAL ABLATION TO THE LEFT VENTRICLE OUTFLOW TRACT (LVOT). NO FURTHER MEDICAL TREATMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. TH

  Patient problems: Heart Block

  MAUDE report 15036847 ↗
• InjuryApr 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD MALE PATIENT ((B)(6) KG) UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, NO BWI PRODUCT MALFUNCTIONS WERE REPORTED. THERE WAS NO EVIDENCE OF STEAM POP DURING THE ABLATION. NO IMPEDANCE NOR TEMPERATURE ISSUES OCCURRED; HOWEVER, THE PATIENT COMPLAINED ABOUT PAIN. THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE PATIENT RETURNED TO THE WARD AND EXPERIENCED CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS DONE TO DRAIN THE FLUID. PATIENT¿S CONDITION IMPROVED. THERE¿S NO REPORT OF PROLONGED HOSPITALIZATION. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE EVENT IS THAT IT WAS PROCEDURE RELATED AND THAT IT COULD HAVE OCCURRED DURING THE ABLATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 11749311 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE ON THE LEFT BASAL POSTEROSEPTAL REGION OF THE LEFT VENTRICLE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. PRIOR TO THE PROCEDURE, THE CT SCAN SHOWED A MILD EFFUSION. THIRTEEN RADIOFREQUENCY (RF) APPLICATIONS WERE APPLIED TO THE PVC ORIGIN IN THE LEFT VENTRICLE (LV). THE PATIENT¿S BLOOD PRESSURE DROPPED AT THE LAST RF APPLICATION. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE FLUID FROM THE PERICARDIUM. PATIENT WAS REPORTED TO BE STABLE THROUGHOUT THE PROCEDURE. THE PVC ABLATION COULD BE COMPLETED SUCCESSFULLY. PATIENT IS PLANNED TO BE DISCHARGED AT THE FOLLOWING DAY AS PER PROTOCOL. THERE¿S NO INFORMATION REGARDING PHYSICIAN¿S CAUSALITY OPINION. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. 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 7993860 ↗