BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1880319 · Received October 20, 2010

    Report

    Report Number
    2242352-2010-03131
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON SEPTEMBER 30, 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE C-RING WAS SPLIT IN HALF. THE OTHER HALF OF THE C-RING AND THE ENTIRE SCOPE WASH TUBING WERE RECEIVED SEPARATE. THE TIP OF THE DETACHED TUBING WAS BENT. THERE WAS SOME EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED FAILURE, "C-RING FELL OFF" WAS CONFIRMED. 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 C-RING ON THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM BROKE OFF INSIDE THE PATIENT'S LEG. A 5 TO 6 CM INCISION WAS CREATED TO REMOVE THE PIECE WITH NO OTHER PATIENT EFFECTS REPORTED. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED.

    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 25018267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention