BEUDAMED
    FDA Adverse Event Other Summary report: N

    FANELLI BILIARY STENT SET

    MDR report key: 502587 · Received December 1, 2003

    Report

    Report Number
    1820334-2003-00257
    Event Type
    Other
    Date Received
    December 1, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 10, 2003
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE STENT WAS BEING PLACED AND DURING DEPLOYMENT AND REMOVAL OF THE INNER CANNULA, THE MARKER BANDS CAME OFF AND REMAINED WITHIN THE STENT LUMEN. SOME ANGULATION WAS PRESENT BECAUSE OF A LOW INSERTION OF CYSTIC DUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FANELLI BILIARY STENT SET BILIARY STENT FGE COOK, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other