BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1041164 · Received May 12, 2008

    Report

    Report Number
    3004114958-2008-00017
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 12, 2008
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K063644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SUBJECT DEVICE WAS USED IN CABG. HOOD OF BYPASS GRAFT REQUIRED STITCH TO ACHIEVE COMPLETE HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT XA DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention