BEUDAMED
    FDA Adverse Event Death Summary report: N

    STSF NAV

    MDR report key: 19616067 · Received June 25, 2024

    Report

    Report Number
    MW5156610
    Event Type
    Death
    Date Received
    June 25, 2024
    Report Date
    May 23, 2024
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A PULSED FIELD ABLATION PROCEDURE A PATIENT DEATH OCCURRED. ICE (INTRACARDIAC ECHOCARDIOGRAPHY) WAS CONSULTED AT THE START OF THE PROCEDURE AND CHECKED AGAIN AT THE END OF THE CASE, NO CHANGES IN THE PERICARDIAL SPACE WERE OBSERVED AT THAT TIME AND THE PATIENT WAS STABLE WHEN MOVED TO RECOVERY. DUE TO THE AFTERNOON TIMING OF THE PROCEDURE, THE PATIENT WAS KEPT OVERNIGHT FOR THEIR RECOVERY PERIOD. EARLY THE MORNING AFTER THE PROCEDURE, APPROXIMATELY 1 AM, CARDIAC TAMPONADE WAS IDENTIFIED. DRAINAGE WAS PERFORMED AND CARDIOPULMONARY RESUSCITATION WAS REQUIRED, AFTER WHICH THE PATIENT WAS ADMITTED TO THE CARDIAC INTENSIVE CARE UNTIL THE PATIENT DIED LATER THAT SAME EVENING. THE OFFICIAL CAUSE OF DEATH HAS NOT YET BEEN DETERMINED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578691 STSF NAV CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| H