BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 3871280 · Received April 15, 2014

    Report

    Report Number
    2242352-2014-00426
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WERE INSIDE 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 FAIL 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 BYPASS PROCEDURE. THE HEARTSTRING III FAILED TO LOAD PROPERLY. THE SEAL REMAINED INSIDE THE LOADER. 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
    230640 HS III PROXIMAL SEAL SYTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25092967

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR