BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23606850 · Received November 20, 2025

    Report

    Report Number
    2029046-2025-03863
    Event Type
    Death
    Date Received
    November 20, 2025
    Date of Event
    May 26, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. PROCESSED AN ESTIMATED DATE OF DEATH AS (B)(6) 2025 AS AN ATRIO-ESOPHAGEAL FISTULA DIAGNOSIS TIMEFRAME USUALLY OCCURS WEEKS AFTER THE ABLATION PROCEDURE AND THE EVENT STATED THAT THE ABLATION PROCEDURE WAS IN (B)(6) 2025. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 20-NOV-2025. THE EXACT DATE OF DEATH IS UNKNOWN, BUT IT WAS IN JUNE. THE PROCEDURE WAS ON THE (B)(6) 2025. THE ENERGY USED FOR ABLATIONS WAS RADIO FREQUENCY (RF). THE FORCE VISUALIZATION FEATURES USED WERE GRAPH, DASHBOARD, VECTOR AND VISITAG. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE 3MM RANGE AND 3SECONDS STABILITY WITH FORCE CRITERIA: 25%, >3G. NO ADDITIONAL FILTER WAS USED WITH VISITAG. THE COLOR OPTION USED PROSPECTIVELY WAS OTHER: ABLATION INDEX. THE GENERATOR AND PUMP USED WERE THE NGEN RF GENERATOR SN (B)(6) AND NGEN PUMP (B)(6). THEREFORE, UPDATED THE D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES SECTION. IN ADDITION, SINCE THE PROCEDURE DATE WAS PROVIDED, ADDED THE DATE UNDER B3. DATE OF EVENT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE NGEN GENERATOR. THE PATIENT SUFFERED AN ATRIO-ESOPHAGEAL FISTULA WHICH RESULTED IN DEATH. IT WAS REPORTED THAT A PHYSICIAN INDICATED THAT A PATIENT HAD AN ATRIO-ESOPHAGEAL FISTULA DIAGNOSED AFTER A PERSISTENT ATRIAL FIBRILLATION ABLATION PERFORMED WITH THE CARTO SYSTEM USING A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT DIED BECAUSE OF THE FISTULA. THE PROCEDURE WAS AN AF REDO PROCEDURE WITH PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ABLATION WITH THERMOCOOL SMARTTOUCH SF CATHETER. ABLATION AT 40W AIMING 400 ABLATION INDEX WITH AVERAGE CF BETWEEN 10 AND 20G. NO ADVERSE EVENT OCCURRED DURING THE PROCEDURE. THE ABLATION PROCEDURE WAS IN (B)(6) 2025. THE DATES OF THE FISTULA DIAGNOSIS AND OF PATIENT¿S DEATH WAS UNKNOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ADVERSE EVENT WAS ASSESSED MDR REPORTABLE UNDER BOTH THE THERMOCOOL SMARTTOUCH SF CATHETER AND THE NGEN GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2468403 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death NGEN PUMP, EU CONFIGURATION| NGEN RF GENERATOR| UNK_CARTO 3| UNK_NGEN RF GENERATOR