BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2854559 · Received November 29, 2012

    Report

    Report Number
    2242352-2012-01256
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES ARE NOT AVAILABLE TO BE RETURNED TO US, TECHNICAL EVALUATIONS CANNOT BE PERFORMED. PER OUR STANDARD SOP¿S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. 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 A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III DEVICES MALFUNCTIONED. THE FIRST HEARTSTRING III SEAL DID NOT ROLL CORRECTLY AND THE SECOND SEAL FAILED TO LOAD PROPERLY. A THIRD HEARTSTRING III SEAL WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCTS IN QUESTION.

    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 25045660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA