BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-PORT XA DISTAL ANASTOMOSIS SYSTEM

    MDR report key: 855141 · Received May 23, 2007

    Report

    Report Number
    3004114958-2007-00003
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 22, 2007
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K063644
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO VISUAL COMPONENT DAMAGE. THE DEVICE WAS IN THE PARTIALLY DEPLOYED STATE. THE KNIFE WAS 1/3 DEPLOYED, FLIPPED UP AT THE BEGINNING OF STROKE. THE KNIFE WAS COMPLETELY VISIBLE AND STICKING OUT. ALL THE CLIPS WERE COMPLETELY DEPLOYED EXCEPT R1 AND L1. THESE TWO REMAINING CLIPS WERE PROTRUDING INTO THE CARTRIDGE AS IF ABOUT TO BE DEPLOYED. THE TWO REMAINING CLIPS WERE NOT DAMAGED. THE DEPLOYMENT PISTON IN THE MANIFOLD WAS ONLY 1/2 WAY DEPLOYED. THE KNIFE WAS MANUALLY SLID BACK AND FORTH TO CONFIRM FUNCTIONALITY. IT MANUALLY SLID BACK AND FORTH SMOOTHLY. THE WEDGE WAS ALSO MANUALLY SLID BACK AND FORTH TO CONFIRM FUNCTIONALITY. IT MANUALLY SLID BACK AND FORTH SMOOTHLY. DEVICE WAS TAKEN APART FOR FURTHER EVALUATION. THE DEPLOYMENT AND CLAMPING CABLES WERE WRAPPED AROUND 360 DEGREES CAUSING KINKS ON BOTH CABLES. THIS IS THE ROOT CAUSE FOR PARTIAL DEPLOYMENT. KINKED CABLES ADDS FRICTION WHICH REDUCES THE AMOUNT OF FORCE REQUIRED BY THE HEAD OF THE DEVICE TO DEPLOY. REVIEW OF LOT 70316A SHOWED THAT IT WENT THROUGH APPROPRIATE MANUFACTURING PROCESS AND QUALITY INSPECTION. THERE WAS NO NCR.

    Description of Event or Problem · 1

    DURING CORONARY ARTERY BYPASS GRAFTING, PHYSICIAN STATED THAT ONLY SOME OF THE CLIPS FIRED THROUGH THE VESSEL WHILE ATTEMPTING AN ANASTOMOSIS WITH THE SUBJECT DEVICE. PHYSICIAN REMOVED THE DEVICE FROM THE VESSEL AND NOTED THAT THE KNIFE WAS STILL DEPLOYED CAUSING DAMAGE TO THE POSTERIOR WALL. VESSEL WAS REPAIRED AND THE PATIENT HAD NO PROBLEMS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-PORT XA DISTAL ANASTOMOSIS SYSTEM FZP CARDICA, INC. NA 70316A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention