MAUDE Adverse Event Report: Cook Inc C-Flex Double Pigtail Ureteral Stent Set; FAD, Stent, Ureteral

Model Number	G14834
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent from a c-flex double pigtail ureteral stent set separated.During an endoscopy procedure on (b)(6) 2026 to remove the stent that had been placed on (b)(6) 2026, the surgeon found black fragments in the patient's bladder that appeared to originate from the stent.The surgeon proceeded to remove a nearly complete ring plus a few fragments.Examination of the stent found the appearance to be unremarkable except for the two missing black bands, one of which is normally present at each end of the stent.No complications occurred during the stone removal procedure; however, there was a risk of stone formation.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - phone number - (b)(6).H3 - device evaluation anticipated but not yet begun.Awaiting device return.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.

• Brand Name: C-Flex Double Pigtail Ureteral Stent Set
• Common Device Name: FAD, Stent, Ureteral
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50793120
• Report Number: 1820334-2026-00977
• Device Sequence Number: 9443195
• Product Code: FAD
• UDI-Device Identifier: 00827002148345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Model Number: G14834
• Device Catalogue Number: 036312
• Device Lot Number: 16936297
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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: Other
• Patient Sex: Unknown