BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3912109 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00545
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    September 26, 2013
    Report Date
    April 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE. THERE WAS SLIGHT EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED INSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND SEAL WERE INSIDE THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. IT APPEARS THAT THE SEAL HAD BEEN PREMATURELY DEPLOYED IN THE LOADING DEVICE. 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 PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III FAILED TO LOAD PROPERLY. THE SEAL REMAINED IN THE DEVICE. 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
    285527 HS III PROXIMAL SEAL SYSTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25083696

    Patients

    Seq Age Sex Outcome Treatment
    1