BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1069893 · Received July 3, 2008

    Report

    Report Number
    MW5007533
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC MICROVASIVE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USING GUIDEWIRE TO PLACE POWER PORT. TIP OF GUIDEWIRE BROKE OFF DURING OPERATIVE PROCEDURE TO PLACE PORT. TIP OF GUIDEWIRE NOTED ON X-RAY BUT UNABLE TO RETRIEVE FROM PATIENT. PHYSICIAN INFORMED PATIENT OF RETAINED GUIDEWIRE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TERUMO RADIOFOCUS GUIDEWIRE DQX BOSTON SCIENTIFIC MICROVASIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other