BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT

    MDR report key: 1032985 · Received April 21, 2008

    Report

    Report Number
    MW5006348
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC SURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VH-3000 VESSEL HARVESTING SYSTEM WAS BEING UTILIZED FOR LEG VEIN RETRIEVAL. A PIECE OF THE VASOVIEW WAS BROKEN IN THE PT'S LEG. PIECE WAS RETRIEVED FROM LEG PRIOR TO CLOSE. NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASOVIEW HEMOPRO VH-3000 GEI BOSTON SCIENTIFIC CARDIAC SURGERY 8021971

    Patients

    Seq Age Sex Outcome Treatment
    1