MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; KOD, CATHETER, UROLOGICAL

Model Number	G14521
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation: director materials management.H3: it is unknown if device is available for 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.
Event or Problem Description
It was reported the or used an open-end flexi-tip ureteral catheter on a patient and mentioned that upon insertion, some of the ureteral catheter shaved off in the patient.They were to retrieve what they could.It is unknown how the pieces were removed or if any were retained.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.There were no adverse effects to the patient reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: d8, d9, h3 and h6 (annex a).H3 - device available for eval: not returned to the manufacturer.Investigation ¿ evaluation: it was reported the or used an open-end flexi-tip ureteral catheter on a patient and mentioned that upon insertion, some of the ureteral catheter shaved off in the patient.They were to retrieve what they could.It is unknown how the pieces were removed or if any were retained.There were no adverse effects to the patient reported.Reviews of documentation including the complaint history, device history record (dhr), quality control (qc) procedures, and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned to cook for evaluation.Therefore, no physical examinations could be conducted.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 related non-conformances that could have contributed to the reported failure mode.A complaint history database search showed no other related complaint associated with the failure mode for the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device provides the following information related to the reported issue: 'precautions: if you encounter resistance while advancing or withdrawing the catheter, stop.Determine the cause of the resistance before proceeding.' based on the available information, no product returned, and the results of the investigation, cook has concluded that the definitive cause of the issue could not be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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.

• 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 (Section G): COOK INC; 750 daniels way; cook inc IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 22730297
• Report Number: 1820334-2025-00940
• Device Sequence Number: 12848195
• Product Code: KOD
• UDI-Device Identifier: 10827002145211
• UDI-Public: (01)10827002145211(17)260330(30)10(10)15299915
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 03/30/2026
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 15299915
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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