BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT

    MDR report key: 2982674 · Received February 21, 2013

    Report

    Report Number
    MW5029135
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    CARDICA INC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PAS-PORT DEVICE MISFIRED REQUIRING FURTHER SURGICAL INTERVENTION AND THE PT TO BE PLACED ONTO BYPASS. DIAGNOSIS OR REASON FOR USE: CABG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75756 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM FZP CARDICA INC FG 000001 111227A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention