BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1081677 · Received July 10, 2008

    Report

    Report Number
    1081677
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WITH DEPLOYMENT OF A STENT, THE GUIDEWIRE FRACTURED, AND THE DISTAL PIECE WAS RETAINED IN THE PATIENT'S DISTAL POPLITEAL ARTERY. IT WAS UNABLE TO BE RETRIEVED. STENTS WERE PLACED AND THE WIRE WAS LEFT EXTRA-LUMINALLY. POST STENT ANGIOGRAM SHOWED A WIDELY PATENT VESSEL WITH THE STENTS AND WIRE EXTRALUMINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC GUIDEWIRE DQX BOSTON SCIENTIFIC .035 STRAIGHT, 150CM 01776242
    2 GLIDECATH CATHETER, IV DQO TERUMO MED CORP. .038, 65 CM 071206

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR