BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOPLASTY WIRE

    MDR report key: 33922 · Received May 7, 1996

    Report

    Report Number
    33922
    Event Type
    Malfunction
    Date Received
    May 7, 1996
    Date of Event
    April 25, 1996
    Report Date
    May 6, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PTCA/DCA/STENT OF RCA USING A .014 CO'S EXTRA SUPPORT 300 CM WIRE. UPON REMOVAL OF THE WIRE THE DISTAL TIP SEPARATED FROM WIRE AND REMAINS IN DISTAL VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOPLASTY WIRE ANGIOPLASTY WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. 22359M-901

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR