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

Catalog Number	RMS-060022-R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	04/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter "on 13jan2020 the device was placed due to chronic hydronephrosis via cystoscopy with retrograde pyelogram.Placement was confirmed via fluoroscopy.Pt presented to ed (b)(6) 2020 with infection symptoms which site reported as uti and aki related to the device.Device was removed emergently on (b)(6) 2020 due to stent dislodgement ((b)(4)) with encrustation and was a device deficiency (already reported (b)(4)).Thick, purulent effluvium released after new stent placed.Note: stent location = right ureter indwell time = 105 days.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 18632300
• Report Number: 3005580113-2024-00012
• Device Sequence Number: 7889522
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)220904(10)C1646870
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2024
• Report Date (Section F): 02/02/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2022
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1646870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Date Device Manufactured: 09/04/2019
• 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 Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 02/02/2024