BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 5653606 · Received May 13, 2016

    Report

    Report Number
    1820334-2016-00380
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    November 21, 2011
    Report Date
    November 22, 2011
    Manufacturer
    COOK UROLOGICAL INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K): K151051. (B)(4). EVENT EVALUATION: THIS HISTORICAL COMPLAINT IS BEING FILED UNDER 21 CFR PART 803 AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THE DEVICE IN THIS CASE WAS RETURNED TO ASSIST WITH THIS INVESTIGATION. EXAMINATION OF THE DEVICE OBSERVED: ONE SPECIMEN CUP CONTAINING A THREE SEGMENTS OF A USED STENT WAS RECEIVED. THE SEPARATED SEGMENTS INCLUDED THE COIL, A STRAIGHT SEGMENT OF THE STENT BODY AND THE REMAINDER OF THE STENT. THE LONGEST SEGMENT OF THE STENT MEASURED 17.7CM AND WAS COVERED WITH ENCRUSTATION. THE SMALL STRAIGHT SEGMENT MEASURED 4.4 CM IN LENGTH AND HAD LIGHT ENCRUSTATION ON THE SURFACE OF THE MATERIAL. THE COILED SEGMENT WAS TIED IN A KNOT 1.7CM FROM THE DISTAL TIP WITH LIGHT ENCRUSTATION ON THE SURFACE OF THE MATERIAL. ALL POINTS OF SEPARATION ON ALL THREE SEGMENTS HAD A JAGGED APPEARANCE AND WERE SEVERELY DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON HOW LONG THIS DEVICE WAS INDWELLING. THE CUSTOMER INDICATED THIS ISSUE OCCURRED WHEN THE STENT WAS INSERTED THE FIRST TIME AND THE PATIENT DID NOT HAVE A STENT IN PRIOR TO THIS; NO LASER WAS USED DURING THE PROCEDURE. A (B)(4) STONE EXTRACTOR WAS USED TO REMOVE THE STENT AFTER THE DIFFICULTY OCCURRED. THE PRODUCT IN THIS CASE, A (B)(4) MULTI-LENGTH URETERAL STENT IS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING INSTRUCTIONS AND INSPECTED IN ACCORDING TO QUALITY CONTROL SPECIFICATIONS. THE APPROPRIATE MANUFACTURING CONTROLS ARE IN PLACE ASSURING FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPMENT. THE DEVICE LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. THE PRODUCT IFU IN THIS CASE STATES: "INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND URINARY SYSTEM ARE UNPREDICTABLE. PERIODIC EVALUATION VIA CYSTOSCOPIC, RADIOGRAPHIC, OR ULTRASONIC MEANS IS SUGGESTED." A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE STENT WAS PASSED OVER A .35 COOK HI WIRE AND WHEN THE STENT REACHED THE RENAL PELVIS IT KNOTTED ON ITSELF. IT WAS DIFFICULT TO REMOVE BUT THE STENT WAS REMOVED AND ANOTHER (B)(4) STENT WAS INSERTED WITHOUT INCIDENCE. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308582 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK UROLOGICAL INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1