BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 14714064 · Received June 16, 2022

    Report

    Report Number
    1820334-2022-01077
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 29, 2022
    Report Date
    June 16, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    10827002147796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME & PRODUCT CODE = LJE- CATHETER, NEPHROSTOMY. (B)(6). OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K181971. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, A BANDER URETERAL DIVERSION STENT MIGRATED FOLLOWING TWO CONSECUTIVE PLACEMENTS. THE DEVICE WAS INITIALLY PLACED FOLLOWING A TOTAL CYSTECTOMY TO REPLACE A PREVIOUSLY INDWELLING STENT (PRODUCT REFERENCE 025807) WITH A DIFFERENT PIGTAIL SHAPE. INITIAL PLACEMENT WAS CONCLUDED SUCCESSFULLY. THE FOLLOWING DAY, THE DEVICE WAS SPONTANEOUSLY EXPELLED FROM THE PATIENT. THE PATIENT RETURNED TO THE HOSPITAL, AND THE STENT WAS REPLACED. THE PATIENT WAS AGAIN DISCHARGED, AND THE DEVICE AGAIN BEGAN TO MIGRATE OUT OF THE PATIENT. THE PATIENT RETURNED, AND THE DEVICE WAS FULLY REMOVED OVER A WIRE GUIDE. A NEW STENT OF THE SAME PRODUCT REFERENCE WAS PLACED WITHOUT FURTHER ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE STENT RETAINERS WERE NOT SUTURED TO THE PATIENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES AND A PERSONNEL INTERVIEW WAS CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. THE DEVICE WAS RETURNED TO COOK WITHOUT PACKAGING OR A LABEL. VISUAL INSPECTION OF THE DEVICE NOTED THAT THE DEVICE WAS SHORTER IN LENGTH AND THE PIGTAIL APPEARED TO BE BROKEN/CUT. AN INQUIRY WITH THE CUSTOMER CONFIRMED THAT IT WAS CUT BY THE USER PRIOR TO IMPLANTATION. 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 RELATED COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE RELEVANT MANUFACTURING DOCUMENTS WERE REVIEWED, AND IT WAS CONCLUDED THAT THE DEVICE WAS FUNCTIONALLY INSPECTED DURING MANUFACTURING AND QUALITY CONTROL. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 1. PASS THE WIRE GUIDE, FLEXIBLE END FIRST, THROUGH THE OPEN END OF THE URETERAL STENT TO STRAIGHTEN THE PIGTAIL COIL. 2. AT THE ANASTOMOSIS SITE, PLACE THE URETERAL STENT, COIL END FIRST, THROUGH THE URETER TO THE RENAL PELVIS. 3. PLACE THE OPPOSITE END OF THE STENT THROUGH THE ILEAL CONDUIT AND OUT THROUGH THE STOMA. 4. REMOVE THE WIRE GUIDE. THE STENT PIGTAIL WILL FORM SPONTANEOUSLY. 5. CHECK TO ASSURE THE STENT HAS FORMED A FULL COIL IN THE RENAL PELVIS. 6. SLIDE THE CATHETER RETAINER ONTO THE EXTERNALIZED PORTION OF THE STENT AND TIGHTEN THE RETAINER ON THE STENT. 7. SUTURE THE RETAINER TO THE SKIN NEAR THE STOMA TO PROVIDE ADDED ASSURANCE AGAINST DISLODGMENT DURING AND FOLLOWING THE PROCEDURE. 8. IF NECESSARY, USE A CONNECTING TUBE (NOT INCLUDED IN THE SET) TO CONNECT THE STENT TO A DRAINAGE BAG. 9. THE CORRECT POSITION OF THE STENT MAY BE CONFIRMED BY RADIOGRAPHIC MEANS. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THE STENT MIGRATION WAS CUSTOMER MISUSE. BASED ON THE CUSTOMER¿S RESPONSE TO COOK¿S ADDITIONAL QUESTIONS, IT APPEARS THAT THE DEVICE WAS MODIFIED BEFORE IMPLANTATION AND THAT THE RETAINER INCLUDED WITH THE SET WAS NOT SUTURED TO THE PATIENT IN CONTRAST WITH THE INSTRUCTIONS FOR USE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

    AS REPORTED, A BANDER URETERAL DIVERSION STENT MIGRATED FOLLOWING TWO CONSECUTIVE PLACEMENTS. THE DEVICE WAS INITIALLY PLACED FOLLOWING A TOTAL CYSTECTOMY TO REPLACE A PREVIOUSLY INDWELLING STENT (PRODUCT REFERENCE 025807) WITH A DIFFERENT PIGTAIL SHAPE. INITIAL PLACEMENT WAS CONCLUDED SUCCESSFULLY. THE FOLLOWING DAY, THE DEVICE WAS SPONTANEOUSLY EXPELLED FROM THE PATIENT. THE PATIENT RETURNED TO THE HOSPITAL, AND THE STENT WAS REPLACED. THE PATIENT WAS AGAIN DISCHARGED, AND THE DEVICE AGAIN BEGAN TO MIGRATE OUT OF THE PATIENT. THE PATIENT RETURNED, AND THE DEVICE WAS FULLY REMOVED OVER A WIRE GUIDE. A NEW STENT OF THE SAME PRODUCT REFERENCE WAS PLACED WITHOUT FURTHER ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    INFORMATION WAS AVAILABLE BUT INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT. THE STENT RETAINERS WERE NOT SUTURED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208915 BANDER URETERAL DIVERSION STENT SET FAD STENT, URETERAL FAD COOK INC 14389941 10827002147796

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other