MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G14840
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 'sof-flex pediatric double pigtail ureteral stent set' was placed on (b)(6) 2024 for a stent re-implant procedure and fractured at the patients home on (b)(6) 2024.The patient reported to have pain and passed part of the stent at home; the patient then returned to the user facility for removal of the remaining stent fragments removed from the urethra and bladder.Another stent was not placed.The stent was not set to be removed for another 2 wee ks.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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
Summary of event: as reported, a 'sof-flex pediatric double pigtail ureteral stent set' was placed on (b)(6) 2024 for a stent re-implant procedure and fractured at the patients home on (b)(6) 2024.The patient reported to have pain and passed part of the stent at home; the patient then returned to the user facility for removal of the remaining stent fragments removed from the urethra and bladder.Another stent was not placed.The stent was not set to be removed for another 2 weeks.A section of the device did not remain inside the patient¿s body.The patient did not require any other additional intervention or experience any other adverse effects due to this occurrence.Investigation evaluation: reviews of documentation including the complaint history, quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The product was not returned to cook for investigation.Additionally, a document-based investigation evaluation was 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.The product ifu, ¿sof-flex double pigtail stent set¿ provides the following information to the user related to the reported failure mode.Precautions: ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ ¿ periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.¿ 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 PEDIATRIC DOUBLE PIGTAIL 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: 20385678
• Report Number: 1820334-2024-01307
• Device Sequence Number: 6596666
• Product Code: FAD
• UDI-Device Identifier: 00827002148406
• UDI-Public: (01)00827002148406(17)250707(10)14830921
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2025
• Device Model Number: G14840
• Device Catalogue Number: 039516
• Device Lot Number: 14830921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male