BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 1450048 · Received August 25, 2009

    Report

    Report Number
    3004114958-2009-00006
    Event Type
    Injury
    Date Received
    August 25, 2009
    Date of Event
    July 27, 2009
    Report Date
    July 27, 2009
    Manufacturer
    CARDICA, INC.
    Product Code
    NCA
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A CABG CASE. UPON FIRING THE CUTTER OF THE PAS-PORT DEVICE, THE PHYSICIAN NOTICED AN EXCESS OF BLEEDING AND DESCRIBED THE SIZE OF THE HOLE ON THE AORTA AS ABOUT THE SIZE OF AN INDEX AND MIDDLE FINGER WIDTH. THE HOLE WAS CIRCULAR. PHYSICIAN CLOSED THE HOLE AND HAND SEWED THE GRAFT IN A DIFFERENT LOCATION. THE PHYSICIAN NOTED THAT THERE WAS NOTHING VERY PECULIAR ABOUT THE PARTICULAR ANATOMY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCULAR SURGICAL INSTRUMENT NCA CARDICA, INC. FG-000001-09 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention