BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT ANASTOMOSIS DEVICE

    MDR report key: 843922 · Received April 17, 2007

    Report

    Report Number
    3004114958-2007-00001
    Event Type
    Injury
    Date Received
    April 17, 2007
    Date of Event
    March 27, 2006
    Report Date
    April 6, 2006
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    k040832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. NO REMEDIAL ACTION TAKEN AT THIS TIME. REPORTED BLEEDING OR OOZING IS A KNOWN RISK IN GENERAL CABG PROCEDURES INVOLVING INTERRUPTED CLIPS OR SUTURES. IT IS UNCLEAR THAT THIS EVENT IS RELATED TO C-PORT CLIP FORMATION OR DEVICE PERFORMANCE. THIS EVENT WAS REPORTED FORM ONE SOURCE AND IS BEING REPORTED IN GOOD FAITH.

    Description of Event or Problem · 1

    PT UNDERWENT CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE. PT WAS RE-OPERATED ON 1 HOUR POST-OP TO TREAT TAMPONADE AND INCREASED BLEEDING. BLEEDING WAS AT THE PROXIMAL END OF AN ANASTOMOSIS CREATED WITH THE C-PORT ANASTOMOSIS DEVICE. SURGEON STATED IT IS POSSIBLE THAT THERE WAS INCOMPLETE CLIP FORMATION AT THE ANASTOMOSIS, BUT HE SAW NO EVIDENCE OF THE OCCURRENCE. PT WAS DISCHARGED IN 2006. DATE WAS ORIGINALLY REPORTED ONE DAY EARLIER. MANUFACTURER'S REPORT NUMBER WAS INADVERTENTLY NOT INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT ANASTOMOSIS DEVICE C-PORT FZP CARDICA, INC. FG-000050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention