ThermoCool SF NAV BNI35BDCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835003147), received between Oct 31, 2016 and Jul 21, 2022 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND AN INTERNAL COMPONENTS EXPOSED ISSUE OCCURRED. WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING, IT WAS NOTICED THAT THERE WAS A BEND TOWARDS THE DISTAL TIP OF THE CATHETER. IT WAS OBSERVED THAT A WIRE WAS SHOWING NEAR THE DISTAL IVC ELECTRODE. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE CATHETER WAS REPLACED, THE ISSUE RESOLVED AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE BEND AT THE DISTAL TIP OF THE CATHETER WAS ASSESSED AS NOT MDR REPORTABLE. THE INTERNAL COMPONENTS EXPOSED ISSUE WAS ASSESSED AS A MDR REPORTABLE PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071584 ↗
• InjuryNov 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED WHILE THE PATIENT WAS IN THE RECOVERY ROOM AFTER THE PROCEDURE; THE PATIENT APPEARED VERY GRAY, PALE, AND HER BLOOD PRESSURE DROPPED. THE PATIENT WAS TAKEN BACK TO THE PROCEDURE ROOM AND THE PATIENT HAD AN ULTRASOUND THAT CONFIRMED THE PATIENT HAD A PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE AND WAS TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT FOR OVERNIGHT OBSERVATION. THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION. PHYSICIAN¿S CAUSALITY OPINION WAS NOT PROVIDED. TRANSSEPTAL WAS PERFORMED WITH A BRK NEEDLE (ST. JUDE). ABLATION WAS PERFORMED BEFORE THE EVENT. THERE WAS NO EVIDENCE OF STEAM POP. FLOW SETTINGS WERE USED PER THE INSTRUCTIONS FOR USE GUIDELINES. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 10916287 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. POST-PROCEDURE (APPROXIMATELY 20-30 MINUTES), THE PATIENT COMPLAINED ABOUT CHEST PAIN. CARDIAC TAMPONADE WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE PATIENT¿S CHEST WAS OPENED, AND STITCHES WERE PLACED TO REPAIR THE PERFORATION. EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE EVENT. PATIENT¿S OUTCOME IS IMPROVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK-1 TRANSSEPTAL NEEDLE. TWO SL-1 SHEATHS WERE USED DURING THE CASE. THE GENERATOR WAS USED WITH DEFAULT SETTINGS IN POWER CONTROL MODE. THE PHYSICIAN ABLATED 35 WATTS ON RIDGE/ANTERIOR WALL AND 25 WATTS ON POSTERIOR WALL. THE CATHETER IRRIGATION WAS USED WITH DEFAULT SETTINGS. NO ERROR MESSAGES WERE OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 8540741 ↗
• MalfunctionDec 12, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A PACKAGING ISSUE OCCURRED. THE AREA WHERE THE PACKAGE SEALS DID NOT LOOK COMPLETELY SEALED. THE THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER WAS PULLED OUT OF THE BOX AND INSPECTED AND THE PHYSICIAN DIDN'T FEEL COMFORTABLE USING IT. PACKAGING WAS COMPLETELY OPENED BUT THE CATHETER WAS NEVER USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE PACKAGING ISSUE HAS BEEN ASSESSED AS MDR REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8157199 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING ABLATION PHASE, PERICARDIAL EFFUSION WAS DISCOVERED BY FLUORO. CARDIAC TAMPONADE WAS CONFIRMED BY TRANSTHORACIC ECHO (TEE). PERICARDIOCENTESIS WAS PERFORMED TO REMOVE 500CC OF FLUID FROM THE PERICARDIUM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AFTER PERICARDIAL DRAINAGE. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION-RELATED. THERE WERE NO ERROR MESSAGES OBSERVED ON ANY BWI EQUIPMENT DURING THE PROCEDURE. PATIENT¿S RELEVANT HISTORY INCLUDES METASTATIC CANCER. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. A BARD SL1 8.5FR SHEATH WAS USED DURING THE PROCEDURE. THERE¿S NO INFORMATION REGARDING ABLATION PARAMETERS. THE CATHETER IRRIGATION FLOW RANGED FROM 8/15ML/MIN. THE PATIENT DID NOT RECEIVE ANTICOAGULANT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 7902610 ↗
• DeathOct 31, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN IDIOPATHIC LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS AND PERSISTENT ATRIAL FIBRILLATION WITH AN EZ STEER THERMOCOOL SF NAV CATHETER AND SUFFERED A VASCULAR DISSECTION RESULTING IN THE PATIENT'S DEATH. DURING THE PROCEDURE, THE PATIENT DEVELOPED AN AORTIC DISSECTION. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE AORTA. PATIENT EXPIRED DURING SURGICAL PREPARATION. THERE IS NO INFORMATION REGARDING AN AUTOPSY. PHYSICIAN'S OPINION REGARDING THE CAUSE OF DEATH IS THAT IT WAS SECONDARY TO AN AORTIC DISSECTION THAT OCCURRED WHILE CROSSING THE VALVE WITH THE ABLATION CATHETER.

  Patient problems: Aortic Dissection; Death

  MAUDE report 6068199 ↗