BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 2153412 · Received June 29, 2011

    Report

    Report Number
    3004114958-2011-00003
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PAS-PORT DEVICE WAS USED IN AN ON-PUMP CABG SURGERY. THE DEVICE DEPLOYED SUCCESSFULLY; HOWEVER, THE SURGEON REPORTED THE PROXIMAL IMPLANT DISLODGED AFTER THE CROSS-ACTION CLAMP WAS REMOVED BEFORE CHEST CLOSURE. THE CAUSE OF DISLODGEMENT IS UNKNOWN, BUT THE SURGEON BELIEVES THAT THE CLAMP MAY HAVE DISTORTED THE GRAFT. NO SEQUELAE WAS NOTED FOLLOWING THE REPAIR. AS OF THE MOST RECENT REPORT, THE PATIENT WAS REPORTED AS "DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention