BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDICA, INC PASPORT PROXIMAL ANASTAMOSIS SYSTEM

    MDR report key: 5853012 · Received August 8, 2016

    Report

    Report Number
    5853012
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    May 12, 2016
    Report Date
    June 17, 2016
    Manufacturer
    CARDICA, INC
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON UTILIZED AN ANASTOMOSIS DEVICE CALLED PASSPORT. WHEN IT WAS TIME TO DEPLOY THE VEIN, THE TIP/END OF THE DEVICE DID NOT DEPLOY AND DID NOT RELEASE THE VEIN. THE MALFUNCTIONING DEVICE HAD TO BE DISASSEMBLED TO TAKE OUT THE VEIN FROM THE DEVICE. A NEW PASSPORT DEVICE WAS THEN OBTAINED AND UTILIZED. THE LABELLING INDICATED IDENTIFIED: ENDOSCOPIC VEIN HARVEST, CORONARY ARTERY BYPASS GRAFTING. OPEN HEART ANASTAMOSIS DEVICE. ITEM INFORMATION: MANUFACTURER: CARDICA; DESCRIPTION: PAS PORT PROXIMAL ANASTOMOSIS SYSTEM, REFERENCE NUMBER (B)(4), LOT NUMBER: 151022F EXP 07/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505900 CARDICA, INC PASPORT PROXIMAL ANASTAMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC FG-000001 151022F

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR