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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: biomedical engineering tech.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.
Event or Problem Description
It was reported the stiffeners within two ultrathane cope nephroureterostomy sets were difficult to remove from the catheter.After the catheter was advanced to the target site, the inner dilator would not release.The first catheter was withdrawn and a second device of the same lot was advanced to the target site.The same difficulty was experienced, however the stiffener was able to be removed "after some tugging." a photo of the first failed device showed separation of the blue inner dilator.No adverse effects were 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
Investigation ¿ evaluation cook medical inc.Received a complaint on (b)(6).2021 from(b)(6).A representative at (b)(6).Hospital, (b)(6).Michigan, regarding an ultrathane cope nephroureterostomy set ((b)(4).; lot: #14208647).It was reported that after the catheter was advanced to the target site, the inner dilator would not release.The first catheter was withdrawn and a second device of the same lot was advanced to the target site.The same difficulty was experienced, but was able to be removed "after some tugging".The procedure was successfully completed with a new device.As reported, there were no adverse side effects or additional procedures required.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection, were conducted during the investigation.One of the two mentioned sets was returned in a used and damaged condition.A section of the blue flexible stiffener was partially inserted into the catheter, with an.035" tfe coated wire guide inserted into the stiffener.Upon removing both devices from the catheter, it was discovered that the shaft of the blue stiffener showed signs of being accordioned.However, the wire guide was able to be removed.Additionally, a separate section of the blue stiffener was also returned with evidence of material elongation.The proximal hub to the blue stiffener was missing.During table top testing, a dissection of the catheter was performed and confirmed the tubing was within specification.Additionally, the outer diameter of the flexible stiffener also confirmed to be within specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the dhr.The dhr for lot 14208647, the catheter sub-assembly lot (sa14112135), the radiopaque band tubing lots (sa14039188), the nyrt raw material lot (2172837.1) and the catheter tubing raw material lot (2149929.1) records non-conformances.Cook concluded that the recorded non-conformances were not related to this incident.To date, a further search of our database records revealed this complaint to be the only reported complaint associated with the complaint lot number.Since there is objective evidence the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house, in the field and that device was manufactured to current specification.Cook reviewed product labeling.Per the attached ifu, t_nucl_rev4, under the heading precautions: it reads, "when inserting a stiffening cannula into the catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of the suture." based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to component failure without manufacturing or design deficiencies.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: 13063241
• Report Number: 1820334-2021-02731
• Device Sequence Number: 4154026
• Product Code: FAD
• UDI-Device Identifier: 00827002481602
• UDI-Public: (01)00827002481602(17)240913(10)14208647
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 09/13/2024
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-20-NUCL-B-RH
• Device Lot Number: 14208647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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 Age: 80 YR
• Patient Sex: Male