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 Unspecified Kidney or Urinary Problem (4503)

Event Date 04/25/2020

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.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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 18632300
• MDR Text Key: 334444188
• Report Number: 3005580113-2024-00012
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)220904(10)C1646870
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• 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: 02/02/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2024
• 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 Sex: Male
• Patient Weight: 83 KG