BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAS-PORT

    MDR report key: 1372245 · Received April 21, 2009

    Report

    Report Number
    MW5010914
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    April 15, 2009
    Report Date
    April 20, 2009
    Manufacturer
    CARDICA, INC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PAS-PORT DEVICE WAS USED. WHEN DEVICE WAS DEPLOYED - IT DID NOT RELEASE VEIN FROM DEVICE. VEIN HAD TO BE CUT OUT OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTAMOSIS SYSTEM FZP CARDICA, INC 81103A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other