BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3000028 · Received March 8, 2013

    Report

    Report Number
    2242352-2013-00216
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. THE DELIVERY DEVICE WAS RETURNED OUTSIDE OF THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY AND THE ANCHOR TAB WERE INSIDE OF THE LOADING ASSEMBLY AND THE ANCHOR TAB WERE INSIDE OF THE LOADING DEVICE. THE SEAL WAS LOCATED UNDER THE WINDOW OF THE LOADING DEVICE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR FAILURE TO LOAD. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED INT EH LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL REMAINED INSIDE OF THE LOADING DEVICE UPON REMOVING THE DELIVERY DEVICE. 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
    98817 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25067371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA