BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST/EXODUS

    MDR report key: 2024017 · Received March 14, 2011

    Report

    Report Number
    1317056-2011-00022
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FGE
    PMA / PMN Number
    K093392
    Removal / Correction Number
    1317056-02/04/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL, THE EVALUATION OF THE SAMPLE HAS NOT YET BEEN COMPLETED. UPON CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, WHEN REMOVING A 10F BILIARY CATHETER FROM THE PATIENT, BREAKAGE OF THE CATHETER AT THE DISTAL END WAS NOTED. THE CATHETER FRAGMENTS WERE ALL RETAINED BY THE SUTURE STRING. THERE WERE NO PATIENT COMPLICATIONS. THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST/EXODUS CATHETER, BILIARY, DIAGNOSTIC FGE NAVILYST MEDICAL NA 1ML0060705

    Patients

    Seq Age Sex Outcome Treatment
    1