BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2201699 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01052
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNK. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AORTIC CUTTER WAS BEING PREPPED BY REMOVING THE PROTECTIVE CAP AND PRESSING THE SAFETY BUTTON. AT WHICH TIME THE DEVICE MADE A POP NOISE AND IT CRACKED, PARTIALLY OPENING ALONG THE SEAMS ON THE SIDE. THE ACTIVATION BUTTON WAS NOT DEPLOYED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 4.3MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA