BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2202484 · Received August 5, 2011

    Report

    Report Number
    2242352-2011-01071
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A F/U REPORT WILL BE SUBMTTED ONCE THE DEVICE EVAL IS COMPLETE. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WIRES WERE SEPARATING FROM THE JAW. THIS OCCURRED AFTER 75% OF BRANCH LIGATION AND TUNNELPLASTY HAD BEEN COMPLETED. THE HARVESTER STATED "THERE WERE A LOT OF BRANCHES ON THE VEIN, MORE THAN USUAL." A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC. VH-4000 0300001558

    Patients

    Seq Age Sex Outcome Treatment
    1 NI