BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYS 3.8MM

    MDR report key: 3834585 · Received May 2, 2014

    Report

    Report Number
    2242352-2014-00496
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Adverse Event
    Yes
    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 SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE SAFETY LOCK WAS UNLOCKED AND THE ACTUATION BUTTON WAS DEPRESSED. ADD'L EVAL IS REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY 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 HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, WHEN THE AORTIC CUTTER ON THE HEARTSTRING III WAS FIRED IT WOULD NOT RETRACT OUR OF THE AORTA. IT CAUSED A TEAR THAT THE SURGEON ESTIMATED TO BE 6MM-8MM. THEY WERE ABLE TO REPAIR THE TEAR WITH THE KIT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264071 HS III PROXIMAL SEAL SYS 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25093654

    Patients

    Seq Age Sex Outcome Treatment
    1 Other