BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE CATHETER

    MDR report key: 20212339 · Received September 12, 2024

    Report

    Report Number
    MW5159559
    Event Type
    Injury
    Date Received
    September 12, 2024
    Report Date
    April 8, 2025
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    QZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PATIENT HAD A STROKE SHORTLY AFTER ABLATION USING THE VARIPULSE PLATFORM DURING A CLINICAL TRIAL IN THE US (BEFORE FDA APPROVAL). THIS ADVERSE EVENT HAS BEEN REPORTED TO THE FDA. BEFORE THIS EVENT, AT LEAST TWO PATIENTS HAD A SIMILAR COMPLICATION (POSTPROCEDURAL STROKE) USING THE VARIPULSE PLATFORM IN EUROPE (COMMERCIAL RELEASE). THESE EVENTS MIGHT BE RELATED, IT IS UNCLEAR IF THEY WERE REPORTED TO THE FDA.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FOR REPORT MW5159559 ON APRIL 9TH, 2025 TO CORRECT THE PROCODE: QZI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101202 VARIPULSE CATHETER PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BIOSENSE WEBSTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown