BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 1210967 · Received October 23, 2008

    Report

    Report Number
    MW5008753
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE SEPARATED WITH DISTAL EMBOLIZATION AND VESSEL DISSECTION, UNABLE TO REWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT GUIDEWIRE - HI TORQUE WHISPER MS DQX ABBOTT VASCULAR 1005357H 8030791

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR