MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD,STENT, URETERAL

Model Number	G34110
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
After placing a metal ureteral stent, the patient returned to the hospital 10 months later to have the stent replaced.It was found that one side of the stent was filled with stones.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Supplemental report is being submitted due to the completion of the investigation on 13-feb-2026.Device evaluation: 01 rms-060024-r device of lot number c2129848 involved in this complaint was returned to cirl for evaluation open not in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.An image of the device prior to being returned for evaluation were provided.Encrustation is present on the visible pigtail curl.The device involved in the complaint was evaluated in the laboratory on the 08th jan 2026.The following was observed: visual inspection, stent returned, introduction catheter returned with protective tubing, stent examined and severed encrustation observed on one pigtail curl, encrustation cannot be removed, slight encrustation and brown residue observed along body of stent, slight bend observed on pigtail curl with encrustation.Functional inspection: pigtail curls open and form as expected.The reported failure was observed.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use / label: it should be noted that the instructions for use (ifu0020) states the following: "potential adverse events associated with indwelling ureteral stents include: stent encrustation.¿ there is no evidence to suggest the user did not follow the ifu.Clinical image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.A possible root cause can be attributed to a procedural related effect as the ifu which accompanies this device lists stent encrustation as a known complication associated with the use of the device.Confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/ correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer after placing a metal ureteral stent, the patient returned to the hospital 10 months later to have the stent replaced.It was found that one side of the stent was filled with stones.Confirmed quantity of 01 device, confirmed used.A possible root cause can be attributed to a procedural related effect as the ifu which accompanies this device lists stent encrustation as a known complication associated with the use of the device.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 13-feb-2026.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD,STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick ; IE
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23921110
• Report Number: 3001845648-2025-00662
• Device Sequence Number: 21089868
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)270108(10)C2129848
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C2129848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 45 KG