BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1355753 · Received April 2, 2009

    Report

    Report Number
    3004114958-2009-00003
    Event Type
    Injury
    Date Received
    April 2, 2009
    Date of Event
    March 19, 2009
    Report Date
    March 20, 2009
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K063644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN STATED THE ANASTOMOSIS LOOKED GOOD AT THE TIME OF THE PROCEDURE, BUT THE BLEEDING GOT WORSE ONCE THE PT WENT TO THE FLOOR. THE PHYSICIAN BROUGHT THE PT BACK TO SURGERY THE NEXT DAY. THE TOE OF THE ANASTOMOSIS HAD A "STREAM" OF BLOOD FLOWING FROM THE ANASTOMOSIS. THE PHYSICIAN REPAIRED THE ANASTOMOSIS AND NO FURTHER COMPLICATIONS WERE REPORTED. THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. THE PHYSICIAN STATED THAT USUALLY THERE IS SOME BLEEDING FROM THE TOE, BUT IT WILL DRY UP AND THAT HE ALWAYS CHECKS THE ANASTOMOSIS BEFORE HE CLOSES AND IT WAS DRY.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED SURGERY IN 2009, USING THE C-PORT XA DEVICE. SURGERY WAS SUCCESSFUL AND THE PT WAS CLOSED UP. THE NEXT DAY THE PT WAS BROUGHT BACK TO THE OPERATING ROOM DUE TO BLEEDING FROM THE "TOE" OF A C-PORT ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT XA DISTAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA 81110B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention