BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM CANNULA

    MDR report key: 1822715 · Received August 26, 2010

    Report

    Report Number
    2242352-2010-02557
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    May 7, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4) 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE C-RING WAS SPLIT IN HALF. THE OTHER HALF OF THE C-RING AND THE SCOPE WASH TUBING WERE RECEIVED IN THE CANNULA. THE TUBING WAS STRAIGHT AND THE ENTIRE LENGTH WAS PRESENT. THE DEVICE HAD MINIMAL EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "C-RING BROKE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. (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 EVH SYSTEM CANNULA BROKE INSIDE THE PATIENT'S LEG. IT WAS RETRIEVED THROUGH THE ORIGINAL INCISION. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM CANNULA CANNULA GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25006965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other