BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAPULSE PULSED FIELD ABLATION SYSTEM

    MDR report key: 20228451 · Received September 13, 2024

    Report

    Report Number
    MW5159637
    Event Type
    Injury
    Date Received
    September 13, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE COMPLETED A PFA CASE USING BOSTON SCIENTIFIC'S FARAPULSE SYSTEM. DURING THE POST CASE ICE SURVEY, THE PHYSICIAN NOTICED A PERICARDIAL EFFUSION. THEY PERFORMED A PERICARDIAL SYNTHESIS AND MONITORED THE EFFUSION. PHYSICIAN BELIEVES THEY PERFED WITH THE BOSTON WIRE/PFA SYSTEM. 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
    1318405 FARAPULSE PULSED FIELD ABLATION SYSTEM PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown