BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 2163490 · Received June 10, 2011

    Report

    Report Number
    2242352-2011-00603
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE SCOPE WASHING TUBING WAS BROKEN ABOUT 1 CM FROM THE C-RING. THE DETACHED PART WAS STILL IN THE CANNULA AND COULD NOT BE REMOVED FROM THE GUIDE TUBE. THERE WAS NO EVIDENCE OF BLOOD OR SIGNS OF CLINICAL USAGE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "SCOPE WASH TUBING BROKE" 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 VESSEL HARVESTING PROCEDURE, THE VASOVIEW 6 C-RING CAME OUT OF THE BOX BROKEN. THE SCOPE WASH TUBING HAD BROKEN ABOUT 1 CM FROM THE C-RING, BUT WAS STILL IN THE CANNULA. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. TE PRODUCT IS RETURNING. RECEIVED USER FACILITY REPORT ON 27-MAY-2011 (B)(4) WHICH STATED THAT WHEN IT WAS FIRST USED, THE C-RING DID NOT ADVANCE SMOOTHLY AND AFTER REPEATED TRIALS, ONE SIDE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 6 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-2000 25031266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA