ThermoCool SF BDI35DDRTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835002805), received between Aug 24, 2017 and May 10, 2018 — classified as 1 death, 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMay 10, 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 PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A VASCULAR DISSECTION (REQUIRING SURGICAL INTERVENTION) AND DEATH. THE NON-BWI MAPPING CATHETER (BRAND-UNSPECIFIED) WAS INSERTED VIA THE FEMORAL ARTERY AND MAPPING WAS PERFORMED. ABLATION WAS PERFORMED WITH A CELSIUS THERMOCOOL CATHETER AND THE PVCS RESOLVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. TWO HOURS POST-PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. PHYSICIAN SUSPECTED A CARDIAC TAMPONADE. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS INITIATED. OPEN CHEST DRAINAGE WAS ATTEMPTED, BUT NO EVIDENCE OF TAMPONADE WAS OBSERVED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. AUTOPSY REVEALED A VASCULAR DISSECTION IN THE BASE OF THE AORTA. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF DEATH WAS THAT IT WAS SECONDARY TO THE AORTIC DISSECTION. IT WAS ALSO NOTED THAT THE DISSECTION SITE WAS THE APPROACH ROUTE OF THE CATHETERS, BUT ABLATION WAS NOT CONSIDERED A DIRECT FACTOR IN THE DEATH. SINCE THE ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

  Patient problems: Death; Not Applicable; Vascular Dissection

  MAUDE report 7504940 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL SF NON-NAV CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, AFTER MAPPING THE LEFT VENTRICLE WITH A NON-BWI BASKET CATHETER, THE EARLIEST POINT WAS ABLATED WITH A THERMOCOOL SF NON-NAV CATHETER. BASKET CATHETER WAS INSERTED INTO THE RVOT AND MAPPING WAS PERFORMED. PATIENT REPORTED CHEST PAIN AND BECAME HYPOTENSIVE. RVOT ANGIOGRAPHY CONFIRMED THAT CONTRAST MEDIA HAD LEAKED INTO THE PERICARDIAL SPACE. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNSPECIFIED AMOUNT OF FLUID. ON POST-PROCEDURE DAY 1, THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION. PATIENT OUTCOME HAS IMPROVED. IT WAS NOTED THAT THE EVENT OCCURRED DURING MAPPING PHASE AND A NON-BWI MAPPING SYSTEM WAS USED. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN INDICATED THAT THE LOCATION OF INJURY HAD NOT BEEN DETERMINED AND THAT THE PATIENT REPORTED CHEST PAIN WHILE THE NON-BWI BASKET CATHETER WAS BEING WITHDRAWN. PH

  Patient problems: Cardiac Tamponade

  MAUDE report 6817696 ↗