BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 3800503 · Received February 11, 2014

    Report

    Report Number
    2242352-2014-00083
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 17, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE. THERE WAS EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, SEAL ANCHOR WERE INSIDE THE LOADING DEVICE. THE GREEN 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HS III PROXIMAL SEAL CAME APART. 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
    89030 HS III PROXIMAL SEAL SYSTEM 4.3MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25083460

    Patients

    Seq Age Sex Outcome Treatment
    1 NI