BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSED FIELD ABLATION (PFA) CATHETER

    MDR report key: 20631900 · Received November 6, 2024

    Report

    Report Number
    MW5162314
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CASE WENT NORMALLY. THERE WERE NO ISSUES DURING THE CASE. BETWEEN 4 AND 5 HOURS AFTERWARDS, THE PATIENT HAD A STROKE. THE PATIENT IS NOT BEING SENT TO INTERVENTIONAL RADIOLOGY. THE RESULTS OR INTERVENTIONS IS NOT KNOWN AT THIS TIME. THE BIOSENSE EQUIPMENT PERFORMED AS DESIGNED AND HAD NO ISSUES. TWO BIOSENSE CATHETERS WERE USED D160901 AND AN UNKNOWN SOUNDSTAR CATALOG NUMBER SEIMENS 8FR. CARTO 14246 WAS USED. NO BIOSENSE GENERATOR OR PUMP WAS USED. FARAPULSE GENERATOR USED. ANGIOMAX WAS USED INSTEAD OF HEPARIN. HARDWARE DOES NOT NEED TO BE EVALUATED. "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
    1539499 PULSED FIELD ABLATION (PFA) CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown