BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE COPE NEPHROURETEROSTOMY SET

    MDR report key: 20101194 · Received August 29, 2024

    Report

    Report Number
    1820334-2024-01148
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    May 22, 2024
    Report Date
    November 4, 2024
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: SCHEDULING MANAGER. G4: PMA/510(K) #: K171603. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET HAD NO HYDROPHILIC COATING. A NEW DEVICE WAS USED TO COMPLETE THE INTERNAL/EXTERNAL STENT CHANGE PROCEDURE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON (B)(6) 2024. PRELIMINARY INVESTIGATION CONFIRMED THE PRESENCE OF APPROPRIATE COATING. THE FLEXIBLE STIFFENER SHOWED ELONGATION/THINNING NEAR THE HUB; IT WAS DETERMINED THE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES AND DRAWINGS AS WELL AS VISUAL INSPECTION OF THE RETURNED PRODUCT, WERE CONDUCTED DURING THE INVESTIGATION. THE ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS RETURNED IN A USED AND DAMAGED CONDITION. DURING THE INITIAL INVESTIGATION, A VISUAL EXAMINATION DISCOVERED THE SUPPLIED FLEXIBLE STIFFENER WAS WITHIN THE ULTRATHANE COPE NEPHROURETEROSTOMY CATHETER. UPON REMOVING THE FLEXIBLE STIFFENER, IT WAS DISCOVERED THE PRESENCE OF MATERIAL ELONGATION OF THE FLEXIBLE SHAFT. THE INVESTIGATION ALSO DISCOVERED THE BLACK MONOFILAMENT SUTURE LINE WAS BROKEN. THE FLEXIBLE STIFFENER WAS EXAMINED, CONFIRMING THE PRESENCE OF THE APPROPRIATE AMOUNT OF SILICONE COATING ON THE FLEXIBLE STIFFENER. DIMENSIONAL ANALYSIS CONFIRMED THAT THE DEVICE AND COMPONENTS WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE CURRENTLY IN PLACE TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING: THE INSTRUCTIONS FOR USE (IFU) [T_NUCL_REV5, COPE NEPHROURETEROSTOMY STENTS] STATES THE FOLLOWING. HOW SUPPLIED : UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. EVIDENCE GATHERED UPON REVIEW OF THE DMR, IFU, DHR AND THE DEVICE EVALUATION HAS CONCLUDED THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INVESTIGATION FINDINGS, COOK HAS CONCLUDED THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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

    IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET HAD NO HYDROPHILIC COATING. A NEW DEVICE WAS USED TO COMPLETE THE INTERNAL/EXTERNAL STENT CHANGE PROCEDURE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION ON 22AUG2024. PRELIMINARY INVESTIGATION CONFIRMED THE PRESENCE OF APPROPRIATE COATING. THE FLEXIBLE STIFFENER SHOWED ELONGATION/THINNING NEAR THE HUB; IT WAS DETERMINED THE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE, THUS PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355850 ULTRATHANE COPE NEPHROURETEROSTOMY SET FAD STENT, URETERAL FAD COOK INC G48170 15657773

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male