BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA FIRM URETERAL STENT SET

    MDR report key: 8732598 · Received June 25, 2019

    Report

    Report Number
    1820334-2019-01458
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 19, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002234175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. INVESTIGATION EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE OPEN PACKAGE OF THE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED COMPLAINT DEVICE LOT NUMBER. VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE DEVICE WAS MANUFACTURED WITH A MONOFILAMENT TETHER. THE TETHER HAD BEEN STRETCHED TO THE POINT SEPARATION. SEPARATION OCCURRED 26CM FROM THE KNOT. NO DAMAGE TO THE STENT MATERIAL. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: CAUTIONS DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED. 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. THIS STENT FEATURES A MONOFILAMENT TETHER DESIGNED TO BREAK AWAY EASILY WITHOUT DAMAGING THE STENT DURING REMOVAL . THE MONOFILAMENT TETHER DOES HAVE LESS TENSILE STRENGTH THAN THE TEVDEK, WHICH IS A BRAIDED MATERIAL. NO MANUFACTURING ANOMALIES OBSERVED WITH THE PRODUCTS. CUSTOMER DISSATISFIED WITH TETHER PERFORMANCE. THE RETURNED DEVICE WAS FOUND TO HAVE A BROKEN TETHER. THE INCOMING INSPECTION REPORTS FROM THE MONOFILAMENT SUPPLIER INCLUDES PULL TEST DATA. ALL 3 LOTS OF RAW MATERIAL USED IN THIS FINISHED GOODS LOT WERE FOUND TO BE WITHIN SPECIFICATION. THE CAUSE FOR THE BROKEN TETHER COULD NOT BE CONCLUSIVELY DETERMINED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: IT WAS REPORTED, THE TETHERS ARE BREAKING AT THE KNOTS BY THE SLIGHTEST TOUCH. THE STENTS WERE TESTED BY THE ACCOUNT AND FOUND THAT THE TETHER BREAKS EASILY AND THESE TETHERS WERE NOT USED.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K161236. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. THIS EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED DURING KIDNEY/URETER STENT PLACEMENT USING A UNIVERSA FIRM URETERAL STENT SET, THE "STRING LOOSENS AT THE SLIGHTEST TOUCH." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. PHYSICAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE TETHER ON THE DEVICE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525995 UNIVERSA FIRM URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G23417 8964081 10827002234175

    Patients

    Seq Age Sex Outcome Treatment
    1