MAUDE Adverse Event Report: COOK INC SOF-FLEX MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15696
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20494800
• Report Number: 1820334-2024-01374
• Device Sequence Number: 4096015
• Product Code: FAD
• UDI-Device Identifier: 00827002156968
• UDI-Public: (01)00827002156968(17)270313(10)15944642
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G15696
• Device Catalogue Number: 039600-R
• Device Lot Number: 15944642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCI. SENSOR ANGLETIP WG; COOK URETERAL CATH. 6FR; OLYMPUS CAMERA HEAD; OLYMPUS ENDOSCOPIC TOWER/LIGHT; OLYMPUS URF-V3; STORZ CYSTOSCOPE; WOLF URETERORENOSCOPE
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 132 KG