BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE INTERFACE CABLE

    MDR report key: 25276682 · Received May 26, 2026

    Report

    Report Number
    25276682
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    / BIOSENSE WEBSTER, INC. / CABLES/ LEADS / D133701 / INTERFACE CABLE, VARIPULSE CATHETER TO GENERATOR (ORANGE - ORANGE) - HIGH VOLTAGE DETECTED ON ELECTRODES (307). MANUFACTURER RESPONSE FOR CARDIAC CABLES/ LEADS, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31199 STERILE INTERFACE CABLE PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BIOSENSE WEBSTER INC D133701 F100004542

    Patients

    Seq Age Sex Outcome Treatment
    1