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	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the flexible stiffening cannula of a ultrathane cope nephroureterostomy set was difficult to remove.During an unknown procedure, the user noted the flexible stiffening cannula got "stuck" and would not budge when trying to remove it from inside the drainage catheter.The entire device, including the catheter and cannula, were removed and replaced with another like device in which the failure occurred for a second time.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.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
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.On (b)(6) 2023, it was reported the flexible stiffening cannula of a ultrathane cope nephroureterostomy set was difficult to remove.The user noted the flexible stiffening cannula got "stuck" and would not budge when trying to remove it from inside the drainage catheter.The entire device, including the catheter and cannula, were removed and replaced with another like device, in which the failure occurred for a second time.After the second removal of the device, the same type of cook device but of a different length, 26cm, was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.Two used devices were returned to cook for evaluation.Upon visual inspection, both flexible stiffeners were removed from the catheters and kinks were observed towards the proximal end of the stiffeners.An attempt to reinsert the stiffeners into the catheters were unsuccessful due to the noted damage to the stiffeners.The inner diameter of the catheters and the outer diameters of the flexible stiffeners were confirmed to be manufactured to specification.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 one relevant non-conformance that was scrapped for being bent.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." 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 out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has concluded the root cause category would fall under cause traced to component failure, without any design or manufacturing issue.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.
Additional Manufacturer Narrative
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
Additional information was provided on 26sep2023.The patient had a ureter obstruction and ureter recanalisation intervention was performed.The device was placed percutaneous into the ureter to perform int.Ext ureteral drainage.The coating of the device was activated for 2 minutes by a saline syringe.The device was only in place for a couple of seconds before removal.After the second removal of the device, the same type of cook device but of a different length, 26cm, was used to completed the procedure successfully.It was noted the patient had normal anatomy and the user wore latex gloves.No photos, videos, or pathology reports are available.

• 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: 17712664
• Report Number: 1820334-2023-01207
• Device Sequence Number: 11300069
• Product Code: FAD
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)250228(10)14564857
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2023

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Device Lot Number: 14564857
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 11/28/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/03/2023; 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO GLIDEWIRE 0.035.
• Patient Sex: Unknown