BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3213716 · Received July 3, 2013

    Report

    Report Number
    2242352-2013-00628
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO FAILED TO SEAL THREE BRANCHES WHICH RESULTED IN A BLOOD FILLED TUNNEL. THE HOSPITAL REPORTED THAT THERE WAS SIGNIFICANT BLEEDING; HOWEVER, THE PT DID NOT REQUIRE A TRANSFUSION. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCT IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303569 VASO VIEW HEMOPRO ENDOSCROPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25074394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other