BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCE MIDDLE WEIGHT UNIVERSAL GUIDEWIRE

    MDR report key: 954134 · Received July 27, 2007

    Report

    Report Number
    MW5004503
    Event Type
    Injury
    Date Received
    July 27, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 25, 2007
    Manufacturer
    GUIDANT CORP
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF THE PTCA, THE GUIDEWIRE (BMW GUIDANT LOT 7031591) BROKE OFF WHEN THE BALLOON (MONORAIL MAVERICK LOT 9306638) WENT UP. THE BROKEN PIECE ADHERED TO THE BALLOON AND WHEN THE BALLOON WAS REMOVED, THE BROKEN PIECE WAS RETRIEVED WITHOUT INCIDENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCE MIDDLE WEIGHT UNIVERSAL GUIDEWIRE NONE DQX GUIDANT CORP 7031591

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention