BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3081868 · Received April 16, 2013

    Report

    Report Number
    3081868
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING OPEN HEART BYPASS GRAFTING USING THE SAPHENOUS VEIN FROM THE RIGHT LEG. DURING THE MINIMALLY INVASIVE VEIN HARVESTING THE TIP OF THE VEIN HARVEST DEVICE BROKE OFF IN THE PATIENT'S LEG. THE PA WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE LEG WITHOUT INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SAPHENOUS VEIN HARVEST FOR USE IN CARDIAC BYPASS SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164113 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING, COAGULATION GEI MAQUET CARDIOVASCULAR LLC VH-4000 25071718

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR