MAUDE Adverse Event Report: COOK INC ULT8.5-8.5-26-NUCL-B-RH; FAD, STENT, URETERAL

Model Number	G48180
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation: radiology tech.H3: device evaluation anticipated but not yet begun; awaiting device return.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 flexible stiffening cannula included in the ultrathane cope nephroureterostomy set separated inside the catheter.During placement of the nephroureterostomy stent, the flexible stiffening cannula was difficult to remove from the stent.The stent and stiffening cannula were removed together from the patient over the wire guide.Significant force was then required to extract the cannula from the stent; and, in the process, a portion of the stiffening cannula separated.To complete the procedure, the stent was successfully placed in the patient without the stiffening cannula.No unintended portion of the device remains in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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
Additional information: d9 - date returned to mfg.Investigation ¿ evaluation: it was reported that the flexible stiffening cannula included in the ultrathane cope nephroureterostomy set separated inside the catheter.During placement of the nephroureterostomy stent, the flexible stiffening cannula was difficult to remove from the stent.The stent and stiffening cannula were removed together from the patient over the wire guide.Significant force was then required to extract the cannula from the stent; and, in the process, a portion of the stiffening cannula separated.To complete the procedure, the stent was successfully placed in the patient without the stiffening cannula.No unintended portion of the device remains in the patient.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), instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.The ultrathane cope nephroureterostomy set was not returned; only the supplied blue flexible stiffener was received in a used and damaged condition.The investigation confirmed that the hub had separated from the shaft and showed evidence of material elongation.The portion that was not elongated measured within acceptable range.Because the catheter was not provided, verification of dimensional tolerances for the catheter could not be performed.The findings of this investigation revealed no evidence to suggest the device was manufactured out of 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 dhr for the reported complaint device lot and the related subassembly lots did not reveal any related quality control discrepancies.A complaint history search identified no other events reported for the related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The product ifu, [t_nucl_rev5] ¿cope nephroureterostomy stents".Provides the following information: "precautions: a ptfe-coated wire guide must be used with this product.Activate hydrophilic coating, if present, by wetting surface of device with sterile water or saline.For best results, maintain wetted condition of device during placement.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: ULT8.5-8.5-26-NUCL-B-RH
• 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: 23099872
• Report Number: 1820334-2025-01162
• Device Sequence Number: 9503526
• Product Code: FAD
• UDI-Device Identifier: 00827002481800
• UDI-Public: (01)00827002481800(17)280611(10)16639271
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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 Model Number: G48180
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Device Lot Number: 16639271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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