BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 3131100 · Received May 23, 2013

    Report

    Report Number
    2242352-2013-00483
    Event Type
    Injury
    Date Received
    May 23, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 CUTTER WAS RESET TO THE ORIGINAL POSITION TO DO A FUNCTIONAL TEST. THE ACTUATION BUTTON WAS DEPRESSED ON THE DEVICE AND IT PERFORMED ACCORDING TO SPECIFICATIONS, NO NON-CONFORMITIES WERE FOUND DURING THE FUNCTIONAL TESTING. THE AORTIC CUTTER WAS VIEWED UNDER A MICROSCOPE; NO NON-CONFORMITIES WERE FOUND. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AFTER ACTUATING THE AORTIC CUTTER ON THE HEARTSTRING III, IT DID NOT CREATE A HOLE IN THE AORTA. A SIDE-BITER CLAMP 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
    229553 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other