BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSA SOFT URETERAL STENT SET

    MDR report key: 5937033 · Received September 8, 2016

    Report

    Report Number
    1820334-2016-00915
    Event Type
    Injury
    Date Received
    September 8, 2016
    Date of Event
    August 10, 2016
    Report Date
    May 8, 2017
    Manufacturer
    COOK INC
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510 (K) #: K151051. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE DRAWINGS, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: THE INSTRUCTIONS FOR USE UNDER WARNINGS, STATE, ¿FORMATION OF KNOTS IN MULTI-LENGTH STENTS MAY OCCUR. THIS MAY RESULT IN INJURY TO THE URETOR DURING REMOVAL AND/OR THE NEED FOR ADDITIONAL SURGICAL INTERVENTION. THE PRESENCE OF A KNOT SHOULD BE CONSIDERED IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING ATTEMPTS AT REMOVAL.¿ THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    REPORTEDLY, A STONE WAS FORMED AROUND A STENT IMPLANTED ON (B)(6) 2016. THE ENCRUSTATION WAS REMOVED ENOUGH TO GAIN ACCESS TO THE CURLS IN THE KIDNEY, BUT THE CURLS HAD FORMED A KNOT IN THE KIDNEY END, PREVENTING IT FROM BEING REMOVED THROUGH CYSTOSCOPY. REMOVAL WAS PERFORMED THROUGH URETEROSCOPY TO RELEASE THE STENT CURLS IN THE KIDNEY THAT WERE ENCRUSTED AND LASERED TO REMOVE THE STENT. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY, A STONE WAS FORMED AROUND A STENT IMPLANTED ON (B)(6) 2016. THE ENCRUSTATION WAS REMOVED ENOUGH TO GAIN ACCESS TO THE CURLS IN THE KIDNEY, BUT THE CURLS HAD FORMED A KNOT IN THE KIDNEY END, PREVENTING IT FROM BEING REMOVED THROUGH CYSTOSCOPY. REMOVAL WAS PERFORMED THROUGH URETEROSCOPY TO RELEASE THE STENT CURLS IN THE KIDNEY THAT WERE ENCRUSTED AND LASERED TO REMOVE THE STENT. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586902 UNIVERSA SOFT URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention