BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO2

    MDR report key: 3082293 · Received April 9, 2013

    Report

    Report Number
    3082293
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    VEIN HARVESTING TECHNICIAN WAS ATTEMPTING TO DO AN ENDOVEIN HARVEST USING THE MAQUET VASOVIEW HEMOPRO2 VESSEL HARVESTING SYSTEM. TECHNICIAN ATTEMPTED TO VISUALIZE THE TUNNEL ALONG THE SAPHENOUS VEIN BUT DISCOVERED THE CO2 INSUFFLATOR WAS INDICATING NO PRESSURE. STAFF VERIFIED ALL CONNECTIONS AND MADE SURE THE CO2 WAS INDEED RUNNING. THE PRESSURE IN THE TUNNEL WOULD NOT MAINTAIN. STAFF CHANGED OUT THE INSUFFLATOR TUBING WITH NO CHANGE. LAST, THEY CHANGED OUT THE MAQUET VASOVIEW HEMOPRO2. WITH THE NEW SYSTEM, STAFF WAS ABLE TO MAINTAIN PRESSURE THAT OPENED UP THE WORKING TUNNEL ALONG THE SAPHENOUS VEIN. STAFF BELIEVE THE PROBLEM WAS WITH THE VALVE ON THE LONG DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VEIN HARVEST (CABG).DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148064 VASOVIEW HEMOPRO2 ELECTROSURGICAL, CUTTING, COAGULATION GEI MAQUET CARDIOVASCULAR LLC VH-4000 25065779

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR