BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 2982941 · Received February 22, 2013

    Report

    Report Number
    2242352-2013-00136
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE HEARTSTRING III DELIVERY DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION; THE LOADING DEVICE WAS NOT RETURNED. THE DELIVERY DEVICE SHOWED NO SIGNS OF CLINICAL USAGE. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND THE SEAL WERE LOCATED INSIDE THE BODY OF THE LOADING DEVICE. THE SEAL WAS UNRAVELED/CRACKED ALONG THE FIRST AND FOURTH ROWS FROM THE OUTER EDGE AND ALONG THE FIFTH ROW FROM THE CENTER OF THE SEAL. THE GREEN SLIDE LOCK WAS UNLOCKED; THE WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. 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 SEAL WAS CRACKED. 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
    77991 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25068295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA