BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMOCLIP

    MDR report key: 528889 · Received June 4, 2004

    Report

    Report Number
    528889
    Event Type
    Death
    Date Received
    June 4, 2004
    Date of Event
    April 28, 2004
    Report Date
    June 3, 2004
    Manufacturer
    WECK
    Product Code
    DSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A TRIPLE CORONARY ARTERY BYPASS GRAFT AND AORTIC VALVE REPLACEMENT WITH NO INTRAOPERATIVE COMPLICATIONS. UPON ARRIVAL IN CICU HEMORRHAGE WAS VISIBLE THROUGH THE CHEST TUBE ACCOMPANIED BY A PERCIPITOUS DROP IN BLOOD PRESSURE. THE PT WAS REOPENED AND MASSIVE HEMORRHAGING AND CARDIAC TAMPONADE OBSERVED. SURGICAL CLIPS WERE MISSING FROM TWO BRANCHES OF THE RT CORONARY ARTERY. THE PT EXPIRED AFTER 30 MINUTES OF OPEN CARDIAC RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCLIP TITANIUM LIGATING CLIP DSS WECK 523800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death