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

Model Number	G34110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations via cri observation study complaint form: (b)(6) 2024 subject diagnosed with sepsis/urosepsis.Admitted to the hospital in icu.Medical treatment with antibiotics and vasopressors.Site related to resonance metallic ureteral stent.Site stated: on ct exam the report stated that the stent may be malfunctioning.Per pi he stated that this was an adverse event and complication of the stent.Also related this to pre-existing condition as this relates to the nature of disease.Patient has history of horseshoe kidney and past nephrectomy.Admitted to hospital/icu.Volume resuscitation and vasopressors given.Completed study.
Additional Manufacturer Narrative
Supplemental correction report is being submitted following additional information received (originator contacted to update description of event to change the date mentioned) on(b)(6)2025.
Event or Problem Description
Supplemental correction report is being submitted following additional information received (originator contacted to update description of event to change the date mentioned) on (b)(6)2025.As reported to customer relations via cri observation study complaint form: (b)(6)2019 subject diagnosed with sepsis/urosepsis.Admitted to the hospital in icu.Medical treatment with antibiotics and vasopressors.Site related to resonance metallic ureteral stent.Site stated: on ct exam the report stated that the stent may be malfunctioning.Per pi he stated that this was an adverse event and complication of the stent.Also related this to pre-existing condition as this relates to the nature of disease.Patient has history of horseshoe kidney and past nephrectomy.Admitted to hospital/icu.Volume resuscitation and vasopressors given.Completed study.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 11-jun-2025.
Additional Manufacturer Narrative
Device evaluation: an adverse event has been reported without a device problem.A device malfunction was not reported.Trending will monitor if any future investigation is required.01 x rms-060024-r device of lot number c1618099 involved in this complaint was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing record review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1618099.A review of the manufacturing records for rms-060024-r of lot number c1618099 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label: it should be noted that according to the instructions for use (ifu0020) that the potential complications associated with " indwelling ureteral stents include: infection, pain/discomfort, hydronephrosis." there is no evidence to suggest that the customer did not follow the instructions for use.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: 1.The ct scan demonstrates a resonance stent in good position in the right collecting system.Despite being in good position, there is severe hydronephrosis and mild perinephric stranding, a finding that suggests pyelonephritis.The constellation of the findings, in the presence of clinical urosepsis, the stent does not appear to be functioning properly.The etiology of the malfunction is not determined on this study.2.There are many potential etiologies of stent malfunction, including but not limited to long dwell time, encrustation, and bacterial infection causing purulent, thick urine not able to drain through the stent.It is uncertain if the stent malfunction resulted in the clinical scenario or if the infection resulted in the stent malfunction.If the stent had a dwell time longer than the ifu recommends, this could have resulted in encrustation, with decreased drainage resulting in a perfect scenario for uti/pyelonephritis to occur.Without more clinical/background information, it is impossible to determine the exact etiology of the stent malfunction.Root cause analysis: definitive root cause could not be determined.A possible root cause could be attributed to the stent.Infection is a common adverse event associated with the use of this device and is covered in the ifu.Another possible cause could be attributed to the patients pre-existing conditions.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary: confirmed quantity of 1 device, confirmed used.Investigation findings conclude that a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the stent.Infection is a common adverse event associated with the use of this device and is covered in the ifu.Another possible cause could be attributed to the patients pre-existing conditions.Complaint is confirmed based on customer and/or rep testimony.Patient outcome according to the initial reporter, the patient was diagnosed with sepsis/urosepsis.Admitted to the hospital in icu.Medical treatment with antibiotics and vasopressors.Site related to resonance metallic ureteral stent.Site stated: on ct exam the report stated that the stent may be malfunctioning.Per pi he stated that this was an adverse event and complication of the stent.Also related this to pre-existing condition as this relates to the nature of disease.Patient has history of horseshoe kidney and past nephrectomy.Complaints of this nature will continue to be monitored for similar events.

• 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: 21091495
• Report Number: 3001845648-2025-00007
• Device Sequence Number: 15617557
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)220529(10)C1618099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1618099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2019
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 10/30/2019; 12/11/2024
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/23/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 57 KG