BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE SET

    MDR report key: 645485 · Received November 9, 2005

    Report

    Report Number
    1820334-2005-00283
    Event Type
    Injury
    Date Received
    November 9, 2005
    Date of Event
    September 15, 2005
    Report Date
    October 21, 2005
    Manufacturer
    COOK, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PTCD PROCEDURE WAS BEING PERFORMED ON A PT WITH A HISTORY OF OBSTRUCTIVE JAUNDICE DUE TO BILE DUCT CANCER. CO WAS ADVISED THAT ALTHOUGH THE PHYSICIAN WAS AWARE OF THE POSSIBILTY OF THE PMG BEING CAUGHT BY THE BEVEL OF THE NEEDLE, DURING HIS ATTEMPT TO GET THROUGH THE AREA OF STENOS, THE PMG BECAME CAUGHT AT THE BEVEL, RESULTING IN THE ELONGATION AND SEPARATION OF THE DISTAL PLATINUM COILED PORTION. APPROC 1CM REMAINED IN THE LEFT BILE DUCT. THERE ARE NO PLANS TO REMOVE THE FRAGMENTED PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET DRAINAGE SET GCY COOK, INC. NA F1740697X

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other