BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3832005 · Received March 7, 2014

    Report

    Report Number
    2242352-2014-00235
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWS NO SIGNS OF CLINICAL USAGE OR EVIDENCE. A VISUAL INSPECTION DETERMINED THAT THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, SEAL AND ANCHORED TAB WERE INSIDE THE DELIVERY DEVICE TUBE. THE PORTION OF THE SEAL NOT LOADED INTO THE DELIVERY DEVICE TUBE FLARED WIDER THAN THE DIAMETER OF THE DELIVERY TUBE. THE GREEN SLIDE LOCK WAS LOCKED AND THE WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, 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 PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, WHILE LOADING THE HS III PROXIMAL SEAL, THE DEVICE MALFUNCTIONED. THE DEVICE WAS PARTIALLY DEPLOYED PRIOR TO USE IN THE STERILE FIELD. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138629 HS III PROXIMAL SEAL SYSTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25089476

    Patients

    Seq Age Sex Outcome Treatment
    1 NI