BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3902613 · Received May 9, 2014

    Report

    Report Number
    2242352-2014-00533
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, SEAL AND ANCHOR TAB WERE INSIDE THE BODY OF THE LOADING DEVICE. THE BLUE SLIDE LOCK WAS LOCKED AND THE WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, 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 NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, WHILE SQUEEZING THE GREEN BUTTONS ON THE LOADER OF THE HEARTSTRING III THE SEAL DID NOT SET PROPERLY. THE SEAL REMAINED INSIDE THE LOADER WHEN THE DELIVERY DEVICE WAS PULLED. 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
    282351 HS III PROXIMAL SEAL ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25087631

    Patients

    Seq Age Sex Outcome Treatment
    1