BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE GUIDE WIRE

    MDR report key: 378413 · Received February 13, 2002

    Report

    Report Number
    MW1024122
    Event Type
    Injury
    Date Received
    February 13, 2002
    Date of Event
    February 4, 2002
    Report Date
    February 13, 2002
    Manufacturer
    GUIDANT, ADVANCED CARDIOVASCULAR SYSTEMS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT END OF PTCA, WIRE (BWM 190CM; GUIDANT CORP. LOT #2012351) WOULD NOT MOVE BACKWARDS. DR ATTENDING, WORKED TO FREE THE WIRE FROM THE PT. UPON REMOVAL THE TIP WAS FOUND TO BE "SPRUNG". CLOSE EXAMINATION REVEALED A VERY SMALL PORTION OF THE TIP REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE GUIDE WIRE GUIDE WIRE DQX GUIDANT, ADVANCED CARDIOVASCULAR SYSTEMS 1001780-HC 2012351

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention