BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 EVH SYSTEM

    MDR report key: 2210414 · Received August 8, 2011

    Report

    Report Number
    2242352-2011-01077
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CAN NOT BE PERFORMED. WE WILL, HOWEVER, CONTINUE TO MONITOR AND TREND THIS TYPE OF EVENT TO ENSURE THAT THERE IS NO COMPROMISE TO QUALITY. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WERE NO NON CONFORMANCE ISSUE(S) WITH THIS PRODUCTION LOT. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE VASOVIEW 6 BISECTOR WAS NOT RETRACTING WELL. THE HARVESTER FELT THAT IT WAS VERY TIGHT BUT USED IT ANYWAY. DURING THE PROCEDURE, THE HARVESTER SAW THAT THE BISECTOR SPARKED. HE TOOK THE UNIT OUT OF THE LEG AND SAW THAT THE BLACK PLASTIC COATING ON THE BISECTOR WAS MELTING FROM THE ACTIVATIONS. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS NOT RETURNING. THE PA THAT WAS HARVESTING STATED THAT THE GENERATOR SETTINGS WERE 25. HE STATED THAT HE'S BEEN USING THIS PRODUCT FOR A WHILE AND NEVER EXPERIENCED ANY ISSUES.

    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 0300001482

    Patients

    Seq Age Sex Outcome Treatment
    1 NI