BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3876144 · Received May 20, 2014

    Report

    Report Number
    2242352-2014-00567
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 23, 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 EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE AND SLIGHT EVIDENCE OF BLOOD. THE DELIVERY SERVICE WAS RETURNED INSIDE THE LOADING DEVICE. THE SEAL, TENSION SPRING ASSEMBLY AND THE ANCHOR TAB WERE INSIDE THE LOADING DEVICE, NOT IN THE DELIVERY DEVICE. THE SEAL WAS OUT OF POSITION DISTAL TO THE DEPLOYMENT DIRECTION AND WAS NOT VISIBLE UNDER THE WINDOW OF THE LOADING DEVICE. THE BLUE SLIDE LOCK AND THE WHITE PLUNGER WERE 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. INTERNAL CORRECTIVE ACTION (WY-2013-35) ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HS III PROXIMAL SEAL FAILED TO LOAD PROPERLY. THE SEAL REMAINED INSIDE THE LOADER WHEN THE DELIVERY DEVICE WAS PULLED OUT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299119 HS III PROXIMAL SEAL ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25085600

    Patients

    Seq Age Sex Outcome Treatment
    1