BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19351758 · Received May 20, 2024

    Report

    Report Number
    2029046-2024-01628
    Event Type
    Death
    Date Received
    May 20, 2024
    Date of Event
    March 18, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    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

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31180020L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 17-MAY-2024. A LIFE THREATENING INJURY. PROLONGED HOSPITALIZATION WITH AN ADMISSION DATE OF (B)(6) 2024 AND DISCHARGE DATE OF (B)(6) 2024. MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. THEREFORE, CHECKED B2. IS HOSPITALIZATION INITIAL/PROLONGED AND ADDED UNDER H6. HEALTH EFFECT - IMPACT CODE "HOSPITALIZATION OR PROLONGED HOSPITALIZATION (F08)". IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05-SEP-2024. A DEATH CERTIFICATE WAS OBTAINED. ADDITIONALLY, THE CONCOMITANT PRODUCT REPORTED IN THE 3500A INITIAL OF AGILIS SHEATH WAS INACTIVATED. 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

    DURING A CLINICAL TRIAL IT WAS REPORTED THAT A PATIENT UNDERWENT AN INDEX ATRIAL FIBRILLATION ABLATION PROCEDURE ON (B)(6) 2024 WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. ON (B)(6) 2024, PATIENT EXPERIENCED AN ATRIO-ESOPHAGEAL FISTULA CATEGORIZED AS SEVERE AND SERIOUS, CATEGORIZED BY SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AS DEFINED BY DEATH. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED AND RELATIONSHIP TO INDEX STUDY PROCEDURE IS CAUSAL. THE ADVERSE EVENT WAS EXPECTED/ANTICIPATED. THE OUTCOME WAS FATAL. INTERVENTION WAS SURGICAL REPAIR OF ATRIO-ESOPHAGEAL FISTULA AND MEDICATION. NO AUTOPSY PERFORMED. SUMMARY OF EVENTS LEADING TO SUBJECTS DEATH: FA ABLATION, ATRIO-ESOPHAGEAL FISTULA, STROKE, INFECTION. NO DEVICE USED TO MONITOR THE ESOPHAGUS DURING THE PROCEDURE. NO CHAR WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615237 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31180020L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death| R| H AGILIS SHEATH| OCTA,LNG,48P,3-3-3-3-3,F-CURVE| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR