BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3843244 · Received March 14, 2014

    Report

    Report Number
    2242352-2014-00371
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SAFETY LOCK WAS UNLOCKED AND THE ACTUATION BUTTON WAS DEPRESSED. THE OUTSIDE CASING WAS SLIGHTLY SEPARATED. ADDITIONAL EVALUATION IS REQUIRED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE AORTIC CUTTER ON THREE HEARTSTRING III MADE A PROPPER AORTOTOMY, BUT THE CASING CRACKED WHEN THEY WERE FIRED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153488 HS III PROXIMAL SEAL SYSTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25087037

    Patients

    Seq Age Sex Outcome Treatment
    1 NI