BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1844681 · Received September 23, 2010

    Report

    Report Number
    2242352-2010-02903
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6) 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THERE WERE NO EXTERNAL NON-CONFORMITIES WITH THE CANNULA OR TISSUE WELDER RECEIVED. SEVERAL PIECES OF WHITE MATERIAL 1 BY 2 MM, WERE FOUND ALONG THE GROOVES OF THE METAL JAW COMPONENTS. WHEN THE HANDLE ADAPTOR WAS DETACHED FROM THE CANNULA, TWO WHITE PIECES OF MATERIAL WERE FOUND ALONG THE INSIDE RIM OF THE COMPONENT. THEY WERE ABOUT 1 MM BY 3 MM LONG, AND 1 MM BY 5 MM LONG. THE HANDLE ADAPTOR COMPONENT WAS THEN FURTHER DISSEMBLED TO INSPECT THE INNER COMPONENTS. IT WAS FOUND THAT THE COMPONENT WHERE THE TOOL SLIDES THROUGH THE CANNULA HAD A GOUGE MARK OF APPROX 25.4 MM IN LENGTH. BASED UPON THE VISUAL OBSERVATIONS, THE COMPLAINT FOR "MATERIAL FOUND IN THE TUNNEL" WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THIS MATERIAL DEBRIS IS SCRAPING OF THE INNER COMPONENT WHEN THE HARVESTING TOOL IS BEING INSERTED IN THE CANNULA. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE HARVESTER DISCOVERED A PIECE OF PLASTIC MATERIAL IN THE TUNNEL OF THE PT'S LEG UPON INSERTION OF THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM. THE PIECE OF MATERIAL WAS RETRIEVED THROUGH THE ORIGINAL INCISION FOR RETURN, BUT WAS SUBSEQUENTLY DROPPED ON THE FLOOR AND NOT ABLE TO BE LOCATED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PT EFFECTS. IT IS SUSPECTED THAT THE SCOPE IS GOUGING THE CANNULA INTERNALLY UPON ENTRY. THE DEVICE (BUT NOT THE DEBRIS) 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 25016067

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other