MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; FAD STENT, URETERAL

Model Number	G48160
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 - device evaluated by mfg? device not returned to manufacturer.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.
Event or Problem Description
It was reported that the catheter from a ultrathane cope nephroureterostomy set leaked.The device was placed in the patient, and the procedure ended at about 16:25 hr.The patient was taken to the floor where catheter leakage was immediately discovered.As a result, the patient was taken back to interventional radiology before 17:00 hr.Where the device was removed and replaced.Customer inspection of the catheter showed the location of the leak was adjacent to the "flange".The customer took the catheter apart and noted a "deformity" of the "flange".No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that the catheter from a ultrathane cope nephroureterostomy set leaked.The device was placed in the patient, and the procedure ended at about 16:25 hr.The patient was taken to the floor where catheter leakage was immediately discovered.As a result, the patient was taken back to interventional radiology before 17:00 hr.Where the device was removed and replaced.Customer inspection of the catheter showed the location of the leak was adjacent to the "flange".The customer took the catheter apart and noted a "deformity" of the "flange".No other adverse effects were reported for this incident.Reviews of the documentation, including the complaint history, quality control procedures, device history record (dhr), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are currently in place to prevent the release of non-conforming products related to the reported failure mode.A review of the dhr for the reported complaint device lot revealed one related non-conformance for "flare inadequate" in which one device was scrapped.A complaint history search did not identify any other events associated with the reported 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 supplied with the device states the following in consideration of the reported failure mode: precautions: "patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter." how supplied "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, it was concluded that component failure contributed to the reported event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY 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 ; IN
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 22117162
• Report Number: 1820334-2025-00625
• Device Sequence Number: 19864263
• Product Code: FAD
• UDI-Device Identifier: 00827002481602
• UDI-Public: (01)00827002481602(17)280303(10)16489764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171603
• 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): 09/25/2025

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: G48160
• Device Catalogue Number: ULT10.2-10.2-20-NUCL-B-RH
• Device Lot Number: 16489764
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown