BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVEWIRE SPIRAL HP CATHETER

    MDR report key: 1083438 · Received July 14, 2008

    Report

    Report Number
    1083438
    Event Type
    Malfunction
    Date Received
    July 14, 2008
    Date of Event
    May 2, 2008
    Report Date
    July 14, 2008
    Manufacturer
    ST. JUDE CARDIOLOGY
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE DOCTOR WAS PUTTING UP THE LIVEWIRE CATHETER (DUODECA) INTO THE PATIENT'S HEART, THE DEVICE PROLAPSED AND GOT STUCK IN THE IVC. IT TOOK THE DOCTOR THREE HOURS OF CONSTANT FINAGALING TO FINALLY LOOSEN THE DEVICE AND REMOVE IT. THE DEVICE FAILURE CAUSED SERIOUS DELAY IN THE PROCEDURE AND COULD HAVE GRAVELY INJURED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVEWIRE SPIRAL HP CATHETER CATHETER, EP DRF ST. JUDE CARDIOLOGY * 2073710

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR