BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1934543 · Received November 23, 2010

    Report

    Report Number
    2242352-2010-03382
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SHORT PORT BALLOON RUPTURED AND BECAME DEFLATED UPON REMOVAL FROM THE LEG. THIS OCCURRED DURING USE BUT NO PIECES FELL INTO THE PATIENT'S LEG. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. IT WAS REPORTED THAT THE BTT (BLUNT TIP TROCAR) BURST INTO PIECES, SO WHAT LITTLE WAS LEFT WAS DISCARDED AND NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25017476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA