BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW ENDOSCOPIC VEIN HARVESTING DEVICE

    MDR report key: 4905601 · Received July 3, 2015

    Report

    Report Number
    MW5043895
    Event Type
    Injury
    Date Received
    July 3, 2015
    Date of Event
    July 27, 2013
    Report Date
    July 3, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, I UNDERWENT A CORONARY BYPASS PROCEDURE. THE VASOVIEW ENDOSCOPIC VEIN HARVESTING DEVICE CAUSED SERIOUS AND LIFE THREATENING INJURY TO MY LEFT LEG. THE MFR'S (MAQUET CARDIOVASCULAR LLC). PLEASE OBTAIN THE PRODUCT CODES AND THE SERIAL NUMBER OF THE VASOVIEW ENDOSCOPIC VEIN HARVESTING MEDICAL DEVICE USED DURING MY CORONARY BYPASS PROCEDURE AT (B)(6) HOSPITAL ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433956 VASOVIEW ENDOSCOPIC VEIN HARVESTING DEVICE VASOVIEW ENDOSCOPIC VEIN HARVESTING DEVICE GEI MAQUET CARDIOVASCULAR LLC PLEASE OBTAIN FROM USER PLEASE OBTAIN FROM USER

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R| S MULTIPLE VITAMIN SUPPLEMENTS