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

Model Number	G14637
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - phone: (b)(6).E3 - occupation: strategic buyer - purchasing & scm.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, during a cystoscopic double j ureteral stent placement to facilitate subsequent surgery, the black marking on the 'c-flex double pigtail ureteral stent set' detached and remained inside the bladder.The marking detached immediately upon entry into the bladder, at the time the catheter was inserted into the ureteral ostium.The detached marking material remained loose within the bladder and could not be removed.The stent was no longer visible, and it was not possible to determine whether the stent was placed correctly.Additional information regarding event outcome has been requested.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h11.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Upon further review, it was determined this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.Per a search of risk documentation and previous complaint data, there is no evidence to suggest that this device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury was alleged, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.

• 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 (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 24674654
• Report Number: 1820334-2026-00311
• Device Sequence Number: 13352276
• Product Code: FAD
• UDI-Device Identifier: 00827002146372
• UDI-Public: (01)00827002146372(17)280812(10)16737257
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: G14637
• Device Catalogue Number: 036310
• Device Lot Number: 16737257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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: Female