BEUDAMED
    FDA Adverse Event Other Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 4581285 · Received March 5, 2015

    Report

    Report Number
    2242352-2015-00132
    Event Type
    Other
    Date Received
    March 5, 2015
    Date of Event
    February 6, 2015
    Report Date
    February 6, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152879 HS III PROXIMAL SEAL SYSTEM 4.3MM PROXIMAL SEAL SYSTEM DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25098383

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR