BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2831326 · Received November 5, 2012

    Report

    Report Number
    2242352-2012-01175
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AFTER DEPLOYING THE HEARTSTRING III SEAL INTO THE AORTA, IT DID NOT UNFOLD PROPERLY. THIS CAUSED PROFUSE BLEEDING IN THE PT. THE SURGEON REMOVED THE SEAL BY FORCE AND PROCEEDED WITH THE OPERATION MANUALLY, WITHOUT A REPLACEMENT DEVICE. THE HOSP WAS UNABLE TO PROVIDE THE AMOUNT OF BLOOD LOSS. THE PT DID NOT REQUIRE A TRANSFUSION. THERE WAS A SLIGHT DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25060606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other