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

Catalog Number RMS-060022-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/27/2020

Event Type  Injury  

Event 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.Device was removed emergently on (b)(6) 2020 due to complication of stent dislodgement and encrustation and was a device deficiency.Site stated ¿emergent procedure for dislodgement and heavily calcified metal stent.Thick, purulent effluvium released after new stent placed." additional file created to capture the stent dislodgement.((b)(4)).

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 18580205
• MDR Text Key: 333733712
• Report Number: 3005580113-2024-00007
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)220904(10)C1646870
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2024

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?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 01/25/2024
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 83 KG