BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAS-PORT

    MDR report key: 5020750 · Received August 21, 2015

    Report

    Report Number
    5020750
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    June 4, 2015
    Report Date
    July 20, 2015
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VEIN GRAFT GOT STUCK IN CHANNEL AND DID NOT THREAD THROUGH PROPERLY. THE SURGEON DID NOT WANT TO RISK USING IT ANY FURTHER. A NEW DEVICE OPENED TO COMPLETE PROCEDURE. MANUFACTURER RESPONSE FOR PAS PORT, PAS PORT (PER SITE REPORTER): TOOK DESCRIPTION OF PROBLEM AND ISSUED RGA# .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553626 PAS-PORT CLIP, IMPLANTABLE FZP CARDICA, INC. FG-000001 140728E

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR