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

Model Number	G14867
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Unspecified Kidney or Urinary Problem (4503); Urolithiasis (4861)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3 = sr.Clinical risk advisor; alberta medical device safety program 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
As reported, the 'sof-flex pediatric double pigtail ureteral stent' contained deposits/calcifications.Urethral stent placement was following kidney transplant.The stent was implanted on (b)(6) 2025 and removed on (b)(6) 2025.Upon removal, the urologist noted the stent was covered in debris, with deposits anchored to the device.The surgeon submitted the device to pathology for identification of the stone/deposit material.Ultrasound findings noted the ureteric stent in situ with associated urothelial thickening, as well as a left lower quadrant drain in situ.No other adverse effects were reported for this incident.

• 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: 25256495
• Report Number: 1820334-2026-00541
• Device Sequence Number: 17500735
• Product Code: FAD
• UDI-Device Identifier: 00827002148673
• UDI-Public: (01)00827002148673(17)280422(10)16568284
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: G14867
• Device Catalogue Number: 039612
• Device Lot Number: 16568284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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
• Patient Sex: Unknown