BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT XCHANGE DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1030122 · Received April 15, 2008

    Report

    Report Number
    3004114958-2008-00015
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 15, 2008
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K073304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT DEVICE WAS USED IN CABG. HOOD OF BYPASS GRAFT REQUIRED STITCH TO ACHIEVE COMPLETE HEMOSTASIS. THE ARTERIOTOMY KNIFE SHIELD MAY HAVE BECOME MISALIGNED DURING GRAFT LOADING AND THIS MAY HAVE CONTRIBUTED TO THE SHIELD NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT XCHANGE DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA 80214E

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention