BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

    MDR report key: 1032187 · Received April 21, 2008

    Report

    Report Number
    1828100-2008-00230
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 21, 2008
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K031891
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS BUT NOT CONCLUDED. NO DEVICE WAS RETURNED TO THE MFR, NOR WAS THE LOT NUMBER OF THE DEVICE REPORTED BY THE USER. THE HARVESTED BLOOD VESSEL WAS SUCCESSFULLY USED AS A CORONARY ARTERY BYPASS GRAFT.

    Description of Event or Problem · 1

    AFTER USE OF THE DEVICE FOR ENDOSCOPIC SAPHENOUS VEIN HARVESTING, THROMBUS WAS FOUND IN THE HARVESTED VEIN. THE HARVESTED VESSEL REMAINED SUITABLE FOR USE AS A CORONARY ARTERY BYPASS GRAFT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM ENDOSCOPIC VEIN HARVESTER GCJ TERUMO CARDIOVASCULAR SYSTEMS CORP. MCVS550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1