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

Catalog Number RMS-060026-R

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  Injury  

Event Description

The physician installed a resonance double j 6 x 26 on a patient on (b)(6) 2023.Today jan 10, the physician communicated that the installed double j has moved hence migrated to the proximal ureter of the patient which leads to a second procedure for replacement.Additional information provided confirmed the stent migrated up the ureter.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 18608182
• MDR Text Key: 334110879
• Report Number: 3005580113-2024-00009
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)260912(10)C2090713
• 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: 01/30/2024

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 Catalogue Number: RMS-060026-R
• Device Lot Number: C2090713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2024
• Distributor Facility Aware Date: 01/10/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2024
• Date Device Manufactured: 09/12/2023
• 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