BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXODUS BILIARY CATHETER 10 FR

    MDR report key: 1941399 · Received December 21, 2010

    Report

    Report Number
    1941399
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 21, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE CATHETER FRACTURED AT SKIN AT THE INSERTION SITE. A GUIDEWIRE WAS PLACED THROUGH THE FRACTURED CATHETER IN AN ATTEMPT TO EXCHANGE IT FOR NEW CATHETER. THE CATHETER COMPLETELY BROKE OFF INTERNALLY AND APPEARED TO BE KINKED OR BENT. THIS RESULTED IN AN ADDITIONAL PROCEDURE FOR A FOREIGN BODY RETRIEVAL. THE PT WAS DISCHARGED AFTER THE RETRIEVAL WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXODUS BILIARY CATHETER 10 FR BILIARY CATHETER FGE NAVILYST MEDICAL * 1ML0060705

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R