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

Catalog Number	RMS-060024-R
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
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.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 21079375
• Report Number: 3005580113-2025-00001
• Device Sequence Number: 15161566
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)220529(10)C1618099
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/06/2025
• Report Date (Section F): 01/06/2025

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 Catalogue Number: RMS-060024-R
• Device Lot Number: C1618099
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2024
• Device Age: 32 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• 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
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Date Report Sent to FDA: 01/06/2025