BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 3603195 · Received January 29, 2014

    Report

    Report Number
    MW5034117
    Event Type
    Other
    Date Received
    January 29, 2014
    Date of Event
    January 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIRST ASSISTANT WAS HARVESTING VEIN FROM PT'S LEG DURING THE PROCEDURE (CABG) ON (B)(6), WHILE USING THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM. DURING THE HARVEST, HE NOTICED THAT SOME OF THE PLASTIC FROM THE TIP OF THE CANNULA HAD BROKEN OFF INTO THE PATIENT. ANOTHER KIT WAS OPENED AND THE PLASTIC WAS RETRIEVED FROM THE PATIENT'S LEG. NO INJURY TO THE PATIENT. REASON FOR USE: TOOL UTILIZED IN CORONARY ARTERY BYPASS GRAFT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62475 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-30000 25088284

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR