BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1962743 · Received January 13, 2011

    Report

    Report Number
    2242352-2010-03974
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THERE WAS A TEAR IN THE SILICON COATING, ABOUT 3 CM LONG FROM THE EDGE TOWARD THE CENTER, WHERE ABOUT HALF OF THE SILICON WAS PEELED BACK ALONG THE SUTURE LINE ON THE PROXIMAL SIDE. THE DEVICE WAS VERY BLOODY. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "SILICON CAME OFF" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT FOLLOWING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE OPERATING ROOM STAFF NOTICED THAT THE SILICON ON THE BALLOON CAME OFF. THIS WAS NOTICED WHEN THE UNIT WAS PULLED OUT OF THE PT'S LEG. THE PROCEDURE WAS COMPLETED WITH THE REPORTED DEVICE. THERE WERE NO PT EFFECTS. THE PART NUMBER AND LOT NUMBER WERE RECEIVED WITH THE RETURNED DEVICE. THE PRODUCT IS RETURNING.

    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 25022360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other