BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2153336 · Received June 30, 2011

    Report

    Report Number
    2242352-2011-00762
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    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: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. 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 HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AFTER DEPLOYMENT OF THE HEARTSTRING III SEAL, A LARGER THAN NORMAL AMOUNT OF BLOOD WAS COMING OUT OF THE AORTA WHERE THE SEAL WAS DEPLOYED. THE SURGEON USED FORCEPS TO GET THE TETHER TO ADJUST THE SEAL, THEN THE TENSION SPRING CAME APART FROM THE SEAL. THE REPORTER FURTHER CLARIFIED BY STATING "THE PROLENE SUTURE WAS INTACT AND CONNECTED TO THE TENSION SPRING. UPON MANIPULATION, THE PROLENE WAS DISLODGED FROM THE SEAL." 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 PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25031989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other