BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 4987885 · Received August 5, 2015

    Report

    Report Number
    2242352-2015-00675
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, HS III PROXIMAL SEAL SYSTEM 3.8MM FAILED TO DEPLOY PROPERLY. A REPLACEMENT DEVICE WAS OPENED AND IT ALSO FAILED TO DEPLOY PROPERLY. A THIRD REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS SIGNIFICANT BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519198 HS III PROXIMAL SEAL SYTEM 3.8MM HS III PROXIMAL SEAL SYTEM DXC MAQUET CARDIOVASCULAR LLC C-HSK-3038 25112360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other