BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2201118 · Received July 29, 2011

    Report

    Report Number
    2242352-2011-01023
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 8, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER IS UNK. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING DID NOT DEPLOY PROPERLY. THE SEAL DIDN'T COME ALL THE WAY OUT OF THE TUBE AND THE SURGEON HAD TO PHYSICALLY PULL IT OUT. THE SAME UNIT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORTEDLY OCCURRED A FEW TIMES; THE EXACT DATES, BATCH INFO AND NUMBER OF OCCURRENCES IS UNK. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA