BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1870828 · Received October 6, 2010

    Report

    Report Number
    2242352-2010-03024
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 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
    VA, 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 THE CONE HAD DETACHED, BUT FORMED A COMPLETE ASSEMBLY WITH THE JUICER BODY, WITH AN EXTREMELY LOOSE FIT (WHERE THE CONE SLIDES OFF WHEN HELD UPSIDE DOWN.) THERE WAS SOME GLUE PRESENT, AND THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED FAILURE "CONICAL TIP CAME OFF" IS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. 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 CONICAL TIP OF THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM CAME OFF INSIDE THE PATIENT'S LEG. THE PIECE WAS RETRIEVED THROUGH THE ORIGINAL INCISION, WITH NO ADDITIONAL 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 25016422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other