BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOURETEROTOMY STENT SET

    MDR report key: 1040595 · Received May 8, 2008

    Report

    Report Number
    1825146-2008-00019
    Event Type
    Injury
    Date Received
    May 8, 2008
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PROPER EVALUATION CANNOT BE PERFORMED AT THIS TIME DUE TO THE PRODUCT NOT BEING RETURNED. HOWEVER, THE DISTRIBUTOR INDICATED THE STENT PORTION THAT WAS REMOVED FROM THE PATIENT WILL BE RETURNED. ADDITIONAL INFORMATION CONCERNING THE PROCEDURE HAS BEEN RECEIVED AS WELL. THE STENT WAS BEING REMOVED FROM THE PATIENT IN 2008 WHEN THE STENT FRACTURED. AS STATED IN THE CUSTOMER STATEMENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE SEGMENT HOWEVER WAS UNSUCCESSFUL. EIGHTEEN DAYS LATER, THE PATIENT HAD THE STENT PORTION REMOVED DURING A PERCUTANEOUS ANTEGRADE STENT REMOVAL - FLANK ACCESS LEAVING THE PATIENT WITH A NEPHROSTOMY TUBE; THE TUBE WAS REMOVED FROM THE PATIENT THE FOLLOWING MONTH. THE PATIENT WAS NOTED TO HAVE COMPLICATIONS BETWEEN PROCEDURES; INFECTION AND HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE DISTRIBUTOR AS WELL AS THE REMOVED PORTION OF THE STENT. A SUPPLEMENT REPORT WILL BE FILED FOLLOWING THE ADDITIONAL INFORMATION AS WELL AS THE EVALUATION OF THE REMOVED SEGMENT.

    Description of Event or Problem · 1

    CUSTOMER STATES: "THE STENT FRACTURED DURING REMOVAL LEAVING A PORTION IN PATIENT. DOCTOR ATTEMPTED URETEROSCOPIC REMOVAL BUT WAS UNSUCCESSFUL. THEY REMOVED IT SURGICALLY AT A LATER DATE. PATIENT IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOURETEROTOMY STENT SET ENDOURETEROTOMY STENT KOD COOK UROLOGICAL, INC. NA UF1412673

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention