BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 1301265 · Received January 29, 2009

    Report

    Report Number
    3004114958-2009-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Date of Event
    December 31, 2008
    Report Date
    December 31, 2008
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K063644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF RETURNED DEVICE PIECES DOES NOT PROVIDE A CLEAR CAUSE FOR THE FAILURE OF THE UNIT. A TEST WAS RUN WITH A C-PORT XA DEVICE FROM LOT 81110B WHERE IT WAS ACTIVATED (PRESSURIZED) AND PLACED IN A 32 DEGREE C BATH. AT 36 MINUTES THE SYSTEM DEVELOPED A SLIGHT BUBBLE LEAK AND AT 43 MINUTES THE LEAK INCREASED. NO RAPID RELEASE OF CO2 OCCURRED DURING THE TEST. POST TEST, THE DEVICE WAS DISASSEMBLED AND THE MANIFOLD INSPECTED FOR ANY STRESS OR FAILURES. NONE WERE FOUND UPON EXAMINATION AND BUBBLE LEAKS ARE ASSUMED TO BE AROUND O-RING POSITIONS FROM EXTENDED PERIOD UNDER PRESSURE AND IN WARM WATER. BASED ON THE EVALUATION, CARDICA IS UNABLE TO DETERMINE ROOT CAUSE FOR DEVICE FAILURE. BENCH TOP TESTING WAS UNABLE TO REPRODUCE FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    THE C-PORT XA DEVICE WAS BEING USED IN AN ARTERY BYPASS CASE WHEN THE PHYSICIAN ALLEGES THAT THE DEVICE WAS LOADED WITH THE VEIN AND THE C-PORT XA DEVICE WAS ENGAGED. THE DEVICE WAS PLACED IN A WARM BASIN ON THE BACK TABLE. THE C-PORT DEVICE WAS LOADED FOR APPROXIMATELY 10 MINUTES WHEN IT RUPTURED. THE WATER IN THE BASIN WAS SPLASHED UP ONTO THE CEILING AND PARTS WERE SPREAD ACROSS THE ROOM. ACCORDING TO THE PHYSICIAN, THERE WERE NO PATIENT OR OPERATING ROOM STAFF CONSEQUENCES.

    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