BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST / EXODUS

    MDR report key: 1931907 · Received December 13, 2010

    Report

    Report Number
    1317056-2010-00082
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 22, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    FGE
    PMA / PMN Number
    K093392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH, IT HAS BEEN REPORTED THAT THE USED DEVICE WILL NOT BE RETURNED FOR EVALUATION, AN INVESTIGATION INTO THIS EVENT IS ON-GOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL, PATIENT HAD 8F DRAINAGE CATHETER IMPLANTED ON (B)(6) 2010. IMMEDIATELY PRIOR TO A PROCEDURE ON (B)(6) 2010 TO REMOVE THE CATHETER, AN X-RAY SHOWED THAT THE CATHETER HAD FRACTURED AND A SEGMENT HAD DETACHED. THE PHYSICIAN PERFORMED A STANDARD CATHETER EXCHANGE, HOWEVER, CHOSE TO LEAVE A SMALL FRAGMENT OF THE ORIGINAL CATHETER IN THE DUODENUM, AS THE FRAGMENT WAS "EXPECTED TO PASS NORMALLY DURING (THE PATIENT'S) NEXT BOWEL MOVEMENT." THE CATHETER EXCHANGE WAS COMPLETED SUCCESSFULLY AND THE PATIENT HAD NO ADVERSE EFFECTS. THE USED DEVICE HAS BEEN DISPOSED OF AT THE HOSPITAL AND WILL NOT BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR