MAUDE Adverse Event Report: Cook Inc. Open-End Flexi-Tip Ureteral Catheter; KOD; Catheter, Urological

Model Number	G14521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to cook that an open-end flexi-tip ureteral catheter " disintegrated." the patient was undergoing a retrograde cystoscopy and pyelography where the open-end flexi-tip ureteral catheter was being used.A ureteroscope from an unknown manufacturer was used.The scope was checked prior to use and no damage was noted.There was no resistance noted upon advancement of the catheter through the scope.It was noted that several fragments of the catheter broke off and required removal from the patient with endoscopic alligator forceps.The catheter was said to be used in the usual manner to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Occupation: (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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: Open-End Flexi-Tip Ureteral Catheter
• Common Device Name: KOD; Catheter, Urological
• 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: 50303229
• Report Number: 1820334-2026-00863
• Device Sequence Number: 16120296
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 16858065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2025
• 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