BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 2201473 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01056
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE. ITEMS MARKED "NI" ARE UNKNOWN TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOVASCULAR VESSEL HARVESTING PROCEDURE, THE VASOVIEW 7X BISECTOR BLADE TOGGLE WAS STICKING. THE REPORTED KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3200 0300001390

    Patients

    Seq Age Sex Outcome Treatment
    1 NI