BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 2211459 · Received August 5, 2011

    Report

    Report Number
    2242352-2011-01061
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SUBMITTED 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 PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, AFTER INSERTING THE VASOVIEW HEMOPRO 2 IN THE CANNULA, THE BLACK PLASTIC SHAFT BROKE JUST BELOW THE JAWS. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE MAQUET TERRITORY MGR WAS PRESENT AND STATED THAT THE HP2 WAS INSERTED PROPERLY INTO THE CANNULA. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    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 0300001505

    Patients

    Seq Age Sex Outcome Treatment
    1 NI