BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILIFORM DOUBLE PIGTAIL URETERAL STENT SET

    MDR report key: 14874221 · Received June 30, 2022

    Report

    Report Number
    1820334-2022-01133
    Event Type
    Malfunction
    Date Received
    June 30, 2022
    Date of Event
    April 19, 2022
    Report Date
    December 7, 2022
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CATALOG NUMBER: DEVICE IS NOT MARKETED IN THE UNITED STATES. THERE ARE SIMILAR DEVICES MARKETED IN THE UNITED STATES, FOR EXAMPLE CATALOG NUMBER 133626-01. INFORMATION FOR 133626-01: COMMON DEVICE NAME: FAD STENT, URETERAL, PRODUCT CODE: FAD, PMA/510(K) #; K172017. (B)(6). 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. B5: ADDITIONAL INFORMATION RECEIVED 11NOV2022. SUMMARY OF EVENT: AS REPORTED, DURING A TRANSURETHRAL URETERAL STENT PLACEMENT, A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS PLACED IN THE LEFT URINARY DUCT ON (B)(6) 2021 (MDR# 1820334-2022-01132). ANOTHER MANUFACTURER'S STENT WAS ALREADY INDWELLING PRIOR TO THIS PROCEDURE. THE SHAPE OF THE OPENING OF THE URETER WAS "UNUSUAL AS IT TOWARDS DOWN." AN X-RAY CHECK WAS NOT PERFORMED. AS THE PREVIOUSLY PLACED STENT ON (B)(6) 2021 WAS NOT VISIBLE UNDER FLUOROSCOPY OR X-RAY IMAGING PERFORMED (B)(6) 2022 AND (B)(6) 2022, A STENT EXCHANGED WAS PLANNED FOR (B)(6) 2022. THE PHYSICIAN DID NOT REMOVE THIS STENT AND PLACED A NEW FILIFORM DOUBLE PIGTAIL URETERAL STENT SET IN THE URINARY DUCT (SUBJECT OF THIS REPORT). PROPER PLACEMENT WAS CONFIRMED WITH FLUOROSCOPY. ON (B)(6) 2022, THE PATIENT UNDERWENT A CT SCAN DUE TO THROAT CANCER AT A DIFFERENT FACILITY AND THE 2 PREVIOUSLY PLACED STENTS WERE FOUND. THE DISTAL END OF ONE STENT WAS FOUND IN THE UPPER URETHRA (MDR# 1820334-2022-01132) AND THE OTHER'S DISTAL END MIGRATED INTO THE URINARY DUCT (SUBJECT OF THIS REPORT). THE PATIENT DENIED TO THE PHYSICIAN HAVING MANUALLY REMOVED ANY OF THE STENTS OR WITNESSING ANY OF THE STENTS BEING EXPELLED. ANTICIPATED STENT REMOVAL DATE IS (B)(6) 2022 AND DEVICE RETURN IS NOT ANTICIPATED. INVESTIGATION EVALUATION: A DOCUMENT-BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A PERSONNEL INTERVIEW, THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. ACCORDINGLY, NO PHYSICAL EXAMINATION COULD BE PERFORMED. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD OR COMPLAINT HISTORY DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS, ¿INDIVIDUAL VARIATIONS OF INTERACTION BETWEEN STENTS AND THE URINARY SYSTEM ARE UNPREDICTABLE. PERIODIC EVALUATION VIA CYSTOSCOPIC, RADIOGRAPHIC, OR ULTRASONIC MEANS IS SUGGESTED.¿ BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THE CAUSE OF THE MIGRATION WAS UNABLE TO BE DETERMINED. IT ISN¿T KNOWN WHETHER THIS STENT WAS THE ORIGINAL STENT, OR THE STENT PLACED AFTER THE ORIGINAL. COOK WAS THEREFORE UNABLE TO DETERMINE IF THE ORIGINALLY PLACED STENT HAD MIGRATED BEFORE THE SECOND STENT WAS PLACED OR IF THE PLACEMENT OF THE SECOND STENT, WITHOUT THE REMOVAL OF THE ORIGINAL STENT, CAUSED THE MIGRATION OF THE ORIGINAL STENT. IN ADDITION, EVEN THOUGH THE SECOND STENT¿S PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY WHEN PLACED, IT IS UNCLEAR IF THIS STENT¿S EVENTUAL MIGRATION WAS INFLUENCED BY THE PRESENCE OF THE ORIGINAL STENT IN THE PATIENT. DUE TO THE PREVIOUSLY LISTED UNKNOWNS, THE FACT THAT THE CUSTOMER IMPLANTED A SECOND STENT WHILE THEY HAD NO REASON TO BELIEVE THAT THE FIRST STENT WAS NO LONGER INSIDE THE PATIENT, ALLUDES TO THE MIGRATION OF BOTH STENTS BEING CUSTOMER MISUSE. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, 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, DURING A TRANSURETHRAL URETERAL STENT PLACEMENT, A FILIFORM DOUBLE PIGTAIL URETERAL STENT SET WAS PLACED IN THE LEFT URINARY DUCT ON (B)(6) 2021 (PATIENT IDENTIFIER (B)(6)). ANOTHER MANUFACTURER'S STENT WAS ALREADY INDWELLING PRIOR TO THIS PROCEDURE. THE SHAPE OF THE OPENING OF THE URETER WAS "UNUSUAL AS IT TOWARDS DOWN." AN X-RAY CHECK WAS NOT PERFORMED. AS THE PREVIOUSLY PLACED STENT ON (B)(6) 2021 WAS NOT VISIBLE UNDER FLUOROSCOPY OR X-RAY IMAGING PERFORMED (B)(6) 2022, A STENT EXCHANGED WAS PLANNED FOR (B)(6) 2022. THE PHYSICIAN DID NOT REMOVE THIS STENT AND PLACED A NEW FILIFORM DOUBLE PIGTAIL URETERAL STENT SET IN THE URINARY DUCT (SUBJECT OF THIS REPORT). PROPER PLACEMENT WAS CONFIRMED WITH FLUOROSCOPY. ON (B)(6) 2022, THE PATIENT UNDERWENT A CT SCAN DUE TO THROAT CANCER AT A DIFFERENT FACILITY AND THE 2 PREVIOUSLY PLACED STENTS WERE FOUND. THE DISTAL END OF ONE STENT WAS FOUND IN THE UPPER URETHRA (PATIENT IDENTIFIER (B)(6)) AND THE OTHER'S DISTAL END MIGRATED INTO THE URINARY DUCT (SUBJECT OF THIS REPORT). THE PATIENT DENIED TO THE PHYSICIAN HAVING MANUALLY REMOVED ANY OF THE STENTS OR WITNESSING ANY OF THE STENTS BEING EXPELLED. PLANS ARE BEING MADE TO REMOVE THE MIGRATED STENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 11NOV2022: PLANNED EXPLANT FOR THIS COMPLAINT (MDR# 1820334-2022-01133) AND RELATED COMPLAINT (MDR# 1820334-2022-01132) IS SCHEDULED FOR 05DEC2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505219 FILIFORM DOUBLE PIGTAIL URETERAL STENT SET Stent, ureteral FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male MEDICON MULTI-LENGTH STENT.