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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
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 blue flexible stiffener was difficult to remove from the catheter included in the ultrathane cope nephroureterostomy set.On the back table, the drain and stiffener were flushed and assembled.The assembly was wiped down.It was then found that the stiffener had become stuck in the catheter.The patient did not experience any adverse effects due to this occurrence.The product malfunction added 10 to 15 minutes to the procedure time.Additional information regarding event details has been requested but is currently unavailable.
Event or Problem Description
Additional information was provided on (b)(6) 2024.The returned device either had direct patient contact or was on a procedure table that had patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that the blue flexible stiffener of the ultrathane cope nephroureterostomy set was difficult to remove from the catheter.On the back table, the drain and stiffener were flushed and assembled.The assembly was wiped down.It was then found that the stiffener had become stuck in the catheter.The patient did not experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used catheter with the supplied blue flexible stiffener was returned to cook for evaluation.Upon visual inspection, the flexible stiffener exhibited extreme material elongation and was stuck onto a wire guide.Due to the condition of the flexible stiffener, the outer diameter could not be verified.The inner diameter of the catheter was measured and confirmed to be within specification.One additional flexible stiffener was also returned and measured.The distal end exhibited jaggedness.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 relevant non-conformances.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Cook also reviewed product labeling.The ifu, t_nucl_rev5, packaged with the device contains the following in relation to the reported failure mode: precautions: "when inserting a stiffening cannula into the catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of the suture.A ptfe-coated wire guide must be used with this product." the information provided upon review of the dmr, ifu, dhr and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or in the field.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.

• 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: 18061702
• Report Number: 1820334-2023-01495
• Device Sequence Number: 6713746
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)250803(10)14875146
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2024

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: 08/03/2025
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 14875146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 02/27/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 01/24/2024; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Patient Sex: Unknown