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

Model Number	G34109
Medical Device Problem Codes	Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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
Description of event.On procedure the stent bent.Reported via phone."as per ccform": whilst pushing the stent into the ureter, the stent bent unsusual, pushing was not possible, we have to remove the stent.After stent change everything worked normal.
Event or Problem Description
Cancellation report is being submitted due to the completion of the investigation on 11-feb-2026.At what point in the procedure did the stent kink? - directly after the orifice.What type and size wire guide was used with the device? - uros-035150-s.Please advise the anatomical location of the intended target site.- kidney, ureter, bladder.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G., kink)? - no.If additional intervention was performed, was it during the same procedure as the device failure or was it scheduled for another day? - same day, same procedure.What is the scope manufacturer and model number that was used? - wolf cystoscope 21 ch.Was the stent stored in strong light e.G., in a pyrix machine or direct sunlight? - no, i brought the stent as rep stock.How did the physician determine the length of the stent to be used for the procedure? - it was a resonance change, so the size was not unknown.But upg was normal.Was resistance encountered when advancing the wire guide into position? - no.Was resistance encountered when advancing the introduction system into position? - no.Was resistance encountered when advancing the stent into position? - yes, but only the complaint stent, the second stent went normal.If resistance was felt how did the physician deal with the resistance encountered? - pushing softly with pusher, but it didn't work, remove the stent.
Additional Manufacturer Narrative
Device evaluation: the rms-060022-r device of lot number c2274292 involved in this complaint was returned for evaluation, with its original opened packaging.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 17th dec 2025.The following was observed in the lab: visual inspection: kink observed on stent approx 4.1cms from pigtail curl.Stent inner wire is intact.Functional inspection: n/a.The reported failure was observed.Manufacturing records: prior to distribution, all rms-060022-r devices are subjected to functional checks and visual inspection to ensure device integrity.A review of the manufacturing records for rms-060022-r of lot number c2274292 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2274292.Instructions for use and/label: it should be noted that the instructions for use (ifu0020) states the following: ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Note: use with wire gide with 0.038" diameter." there is evidence to suggest the user did not follow the ifu as information reported a 0.035"(uros-035150-s) wire guide was used; however, this did not contribute to the reported issue, the wire guide is removed prior to stent advancement so the use of the incorrect size would not have contributed to the issue.Therefore, as per section 6.6.3 of (b)(4) rev009 this have been documented in the pms log.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 could be attributed to difficult patient anatomy and/or a tight stricture.Pressure from the tight stricture may have resulted in increased deployment force, which could lead to stent bending.Additional information indicates that resistance was encountered while advancing the stent into position.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, on procedure the stent bent.Confirmed quantity, 01 device was confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined.A possible root cause could be attributed to difficult patient anatomy and/or a tight stricture.Pressure from the tight stricture may have resulted in increased deployment force, which could lead to stent bending.Additional information indicates that resistance was encountered while advancing the stent into position.Complaint is confirmed based on visual and/or functional inspection.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD,STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 23989454
• Report Number: 3001845648-2026-00016
• Device Sequence Number: 10503275
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)280306(10)C2274292
• Combination Product (Y/N): N
• 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): 02/11/2026
• Report Date (Section F): 11/25/2025

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: G34109
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C2274292
• 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: 11/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male