BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX AQ MULTI-LENGTH URETERAL STENT SET

    MDR report key: 1343868 · Received March 13, 2009

    Report

    Report Number
    1825146-2009-00008
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 3, 2009
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    PMA / PMN Number
    K961446
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED STENT WAS RECEIVED IN THREE SEPARATE SEGMENTS. BASED UPON THE POINTS OF SEPARATION AS WELL AS THE INK MARKS, IT APPEARS THE TOTAL LENGTH OF THE STENT HAS BEEN RETURNED FOR EVALUATION. UPON CLOSE EXAMINATION OF EACH POINT OF SEPARATION, THE SEPARATIONS WERE NOTED TO HAVE OCCURRED AT SIDEPORTS. THE MATERIAL OF THE STENT WAS NOTED TO BE BRITTLE AND CRACKED THROUGHOUT THE PROXIMAL COILS. THE CUSTOMER INDICATED THE STENT BEGAN TO SEPARATE DURING REMOVAL; THE STENT SEGMENTS WERE REMOVED FROM THE PATIENT'S URETER DURING THE SAME PROCEDURE. A COOK UROLOGICAL, INC. SALES REPRESENTATIVE VISITED THE FACILITY AND INDICATED THE STORAGE CONDITIONS WERE ADEQUATE AT THIS TIME. AS STATED IN THE INFORMATION FOR USE BOOKLET, "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE." THE STENT MATERIAL CAN REACT IN UNEXPECTED WAYS DEPENDING ON PATIENT'S INDIVIDUAL BODY CHEMISTRY AS WELL AS MEDICATIONS ADMINISTERED. WE ARE UNABLE TO DETERMINE WHAT HAS CAUSED THE CUSTOMER'S DIFFICULTY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE FORWARDED.

    Description of Event or Problem · 1

    SOF-FLEX MULTI-LENGTH STENT FAILED DURING A CYSTOSCOPIC STENT REMOVAL. AT THIS TIME HE USED A GRASPER TO REMOVE THE STENT WHICH HAD BEEN IN PLACE FOR 6 WEEKS. WHEN PRESSURE WAS APPLIED TO THE GRASPER TO PULL THE STENT OUT, PIECES BROKE FREE FROM THE BODY OF THE STENT AND THE STENT BEGAN FALLING APART. NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX AQ MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL, INC. UF1417885

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention