BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    MDR report key: 20494800 · Received October 21, 2024

    Report

    Report Number
    1820334-2024-01374
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    August 10, 2024
    Report Date
    October 6, 2025
    Manufacturer
    COOK INC
    Product Code
    FAD
    UDI-DI
    00827002156968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: CUSTOMER (PERSON) ADDRESS = (B)(6). G4: PMA/510(K) NUMBER = K180053. 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, UNAVAILABLE, OR UNCHANGED. INVESTIGATION EVALUATION: IT WAS REPORTED THAT THE 'STRINGS' DETACHED FROM THE 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED PATIENT SELF-REMOVAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, AND THE PATIENT ATTEMPTED TO REMOVE THE STENT, AS INSTRUCTED, ON (B)(6) 2024. THE PATIENT RETURNED TO THE CLINICAL SETTING ON (B)(6) 2024 AND RETAINED STENT WAS CONFIRMED VIA IMAGING. THE STENT WAS THEN REMOVED WITH A FLEXIBLE CYSTOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, SPECIFICATIONS, QUALITY CONTROL PROCEDURES, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU) WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER RELATED COMPLAINTS ASSOCIATED WITH DEVICE LOT. BECAUSE 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 LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "PRECAUTIONS -DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. IF RESISTANCE IS ENCOUNTERED, STOP. DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. 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

    IT WAS REPORTED THAT THE 'STRINGS' DETACHED FROM THE 'SOF-FLEX MULTI-LENGTH URETERAL STENT' DURING ATTEMPTED PATIENT SELF-REMOVAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE, AND THE PATIENT ATTEMPTED TO REMOVE THE STENT, AS INSTRUCTED, ON (B)(6) 2024. THE PATIENT RETURNED TO THE CLINICAL SETTING ON (B)(6) 2024 AND RETAINED STENT WAS CONFIRMED VIA IMAGING. THE STENT WAS THEN REMOVED WITH A FLEXIBLE CYSTOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    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
    2219639 SOF-FLEX MULTI-LENGTH URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC G15696 15944642 00827002156968

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male BOSTON SCI. SENSOR ANGLETIP WG| COOK URETERAL CATH. 6FR| OLYMPUS CAMERA HEAD| OLYMPUS ENDOSCOPIC TOWER/LIGHT| OLYMPUS URF-V3| STORZ CYSTOSCOPE| WOLF URETERORENOSCOPE