BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA FIRM URETERAL STENT SET

    MDR report key: 8935043 · Received August 27, 2019

    Report

    Report Number
    1820334-2019-02128
    Event Type
    Malfunction
    Date Received
    August 27, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 13, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B1: NO REPORTABLE PRODUCT PROBLEM OR SERIOUS INJURY OCCURRED. H1: THERE WAS NO REPORTABLE PRODUCT MALFUNCTION. INVESTIGATION/EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED COMPLAINT DEVICE LOT NUMBER. INSPECTION OF THE RETURNED DEVICE WAS THE STENT WITH THE TETHER STILL ATTACHED TO THE STENT. THE PROXIMAL COIL WAS FOUND SMASHED 5 CM FROM THE END OF THE COIL. A CORRELATING SMASHED AREA WAS FOUND DIRECTLY ACROSS FROM THE FIRST SMASHED AREA WHERE THE TUBING LAYS TOGETHER. FUNCTIONAL TESTING WAS PERFORMED BY WIRING THE STENT WITH A 0.035" WIRE GUIDE. THE WIRE GUIDE TRANSITIONED THROUGH THE STENT, BUT DRAG WAS NOTED THROUGH THE DAMAGED AREA. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR LOT 9672210, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: USING A BASELINE PYELOGRAM, ESTIMATE THE PROPER STENT LENGTH; ADD 1 CM TO THAT ESTIMATED URETERAL MEASUREMENT. ACCURATE MEASUREMENT ENHANCES DRAINAGE EFFICIENCY AND PATIENT COMFORT. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A REVIEW OF THE RETURNED DEVICE IDENTIFIED THAT THE TUBING IN THE PROXIMAL PIGTAIL OF THE STENT HAD A SQUASHED APPEARANCE. THE STENT WAS WIRED USING AN APPROPRIATE WIRE GUIDE AND THE WIRE GUIDE PASSED THROUGH THE STENT. THE WIRE GUIDE FELT RESISTANCE AT THE POINTS WHERE THE STENT TUBING WAS OUT OF ROUND. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT FIND ANY RELATED ANOMALIES AND THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR THE LOT AT THE TIME OF THIS INVESTIGATION. THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. THE DAMAGE TO THE STENT OR THE CHOICE OF STENT LENGTH ARE POSSIBLE CONTRIBUTING FACTORS TO THE STENT KINKING. THE DEVICE IS SUPPLIED WITH INSTRUCTIONS FOR USE THAT PROVIDE RECOMMENDATIONS FOR IDENTIFYING THE LENGTH OF STENT NEEDED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K161236. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING AN EVALUATION CASE USING A UNIVERSA FIRM URETERAL STENT SET, THE STENT WAS KINKED AND DID NOT COIL CORRECTLY. THE STENT WAS THEN REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY PLACING A LONGER STENT (28 CM), BECAUSE THEY THOUGHT THE OTHER MIGHT BE TOO SHORT FOR THE PATIENT AND WHY IT DID NOT COIL CORRECTLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730231 UNIVERSA FIRM URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NGAGE BASKET, HIGHWIRE STIFF .035| NGAGE BASKET, HIGHWIRE STIFF .035