BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1192436 · Received October 7, 2008

    Report

    Report Number
    3004114958-2008-00021
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 16, 2008
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K070548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 FLEX-A DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention