BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 3028040 · Received March 27, 2013

    Report

    Report Number
    3004114958-2013-00001
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS RETURNED TO CARDICA AND A FAILURE INVESTIGATION INCLUDING FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE WAS RESET AND A NEW IMPLANT INSTALLED. THE PAS-PORT WAS RELOADED AND THE IMPLANT DRY-FIRED INTO ARTIFICIAL MEDIA. THE IMPLANT WAS DEPLOYED SUCCESSFULLY AND THE DEVICE PERFORMED AS INTENDED. WE CAN REASONABLY CONCLUDE NORMAL FUNCTION OF THE PAS-PORT DEVICE USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    THE PAS-PORT DEVICE WAS USED FOR PROXIMAL ANASTOMOSIS OF SAPHENOUS VEIN GRAFT IN AN OFF-PUMP CORONARY BYPASS SURGERY PERFORMED ON (B)(6) 2013. AFTER DEPLOYMENT OF THE DEVICE THE SURGEON CONTINUED WITH THE PROCEDURE AND OBSERVED BLEEDING FROM THE AORTA. CONTROL OF BLEEDING WAS DIFFICULT SO THE SURGEON CLAMPED THE AORTA AND REMOVED THE IMPLANT. THE AORTA APPEARED SEVERELY DISEASE AND A SECTION OF THE AORTA REQUIRE PLACEMENT OF AN AORTIC PATCH FOR REPAIR. THE CORONARY BYPASS PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126578 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDIOVASCULAR SURGICAL INSTRUMENT FZP CARDICA, INC. NA 111227A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention