BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST EXODUS STANDARD LOOP BILIARY DRAINAGE

    MDR report key: 2018253 · Received March 8, 2011

    Report

    Report Number
    MW5019741
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 8, 2011
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REPLACEMENT OF NAVILYST BILIARY DRAIN THAT WAS PLACED IN (B)(6) 2010, AN X-RAY REVEALED MULTIPLE FRACTURES WITHIN THE PRE-EXISTING CATHETER. PORTIONS OF THE FRACTURED CATHETER WERE ABLE TO BE EXTRACTED, HOWEVER, SOME FRAGMENTS HAD TO BE ADVANCED INTO THE BOWEL. THE PT WAS ADMITTED OVER NIGHT FOR OBSERVATION. EXODUS BILIARY DRAINAGE CATHETER WERE RECALLED (B)(6) 2011 AND ARE NO LONGER IN OUR INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST EXODUS STANDARD LOOP BILIARY DRAINAGE BILIARY CATHETER FGE NAVILYST MEDICAL, INC. SIZE 10 FRENCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization