BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETIX PLUS MODERATE SUPPORT STRAIGHT TIP PTCA GUIDEWIRE

    MDR report key: 1870755 · Received September 22, 2010

    Report

    Report Number
    1870755
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING CARDIAC CATHERIZATION WITH STENT PLACEMENT. KINETIX PTCA GUIDEWIRE INSERTED. AS GUIDEWIRE WAS BEING REMOVED, THE TIP OF GUIDEWIRE BROKE OFF IN THE VESSEL. UNABLE TO RETRIEVE. STENT DEPLOYED OVER THE WIRE TO AFIX TO THE VESSEL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIX PLUS MODERATE SUPPORT STRAIGHT TIP PTCA GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC * 13495591

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR