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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4 ¿ pma/510(k) #: k171603.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 that the catheter of an ultrathane cope nephroureterectomy set leaked.The catheter was used during a nephrostogram with bilateral percutaneous nephroureteral catheter placement.After the catheter was placed, the patient was discharged.Later, leakage at the connection between the hub and one of the catheters was discovered.The patient returned to the facility, and an additional procedure with sedation was performed to remove and replace the catheter.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation it was reported that a catheter from an ultrathane cope nephroureterectomy set required replacement.The catheter was placed during a nephrostogram with bilateral percutaneous occluding nephroureteral catheter placement procedure, and the patient was discharged to home.Later, leakage at the connection between the hub and catheter was discovered.The patient returned to the facility, and an additional procedure with sedation was performed to remove and replace the catheter.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), quality control procedures, and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.The catheter was returned in an opened and used condition.The overall length of the catheter was verified to have a length measurement of approximately 10.0 cm, supporting the shaft of the catheter was cut.During testing, leakage was observed between the cap and mac-loc adaptor, but both the adaptor and cap were confirmed to be free of damage.The gap between the cap and mac-loc adaptor passed the gap requirement.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no recorded non-conformances relevant to the failure mode.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 attached ifu, t_nucl_rev5, cope nephroureterectomy states the following under the heading "how supplied" "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.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 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18606983
• Report Number: 1820334-2024-00136
• Device Sequence Number: 14158427
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)250622(10)14807370
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 06/22/2025
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 14807370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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 Age: 56 YR
• Patient Sex: Female