BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 8341327 · Received February 14, 2019

    Report

    Report Number
    3004114958-2019-00001
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    January 4, 2019
    Report Date
    February 14, 2019
    Manufacturer
    AESDEX, LLC
    Product Code
    FZP
    UDI-DI
    11814900000017
    PMA / PMN Number
    K091017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INCOMPLETE DEVICE WAS RETURNED WITH DAMAGE TO THE DELIVERY SYSTEM NOTED UPON RETURN, WHICH WAS PREVIOUSLY NOT REPORTED. THE USER INDICATED THERE WERE NO ISSUES WITH THE CLIP PRIOR TO USE OR ANY ISSUES DURING THE DELIVERY/ANASTOMOSIS PROCESS. GIVEN THE CONDITION OF THE RETURNED DEVICE, A COMPLETE INVESTIGATION WAS NOT POSSIBLE AND A CONCLUSION REGARDING THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE DEVICE'S CLIP WAS USED TO CREATE THE PROXIMAL ANASTOMOSIS OF A BYPASS GRAFT DURING OPEN CARDIAC BYPASS SURGERY. APPROXIMATELY TWO HOURS AFTER CREATING THE ANASTOMOSIS AND PRIOR TO COMPLETION OF THE SURGERY, THE GRAFT DISLODGED FROM THE AORTA. WHILE USING A PUMP-OXYGENATOR, THE SURGEON REMOVED THE CLIP FROM THE GRAFT AND SUTURED THE GRAFT TO ANOTHER LOCATION. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132203 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP FZP AESDEX, LLC FG-000001 180301B 11814900000017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention