BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE BALANCE MIDDLE WT UNIVERSAL

    MDR report key: 1071608 · Received July 8, 2008

    Report

    Report Number
    MW5007582
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2008, MD INSERTED GUIDEWIRE DURING PROCEDURE & WIRE BROKE. ALL COMPONENTS OF WIRE REMOVED FROM PT - NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI TORQUE BALANCE MIDDLE WT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR 0.014" X 300 CM 8031991

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR