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

Model Number G34109

Device Problems Fracture (1260); Dent in Material (2526)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Per dm's email: (b)(6) the urology coordinator describes that (b)(6) observed a kink/unraveling in the rms stent after deployment during their case yesterday, 11/14/22.The stent was saved and given to the pdc manager (b)(6).Photos included but a bit blurry.No patient injury was sustained during the procedure.A tria stent from boston scientific was then placed instead.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This supplemental report is being submitted as a cancellation report as this file is no longer meets not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ based on the lab evaluation complete on 01-mar-2023.

Manufacturer Narrative

This is a cancellation report, file is no longer reportable.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15994821
• MDR Text Key: 306107462
• Report Number: 3001845648-2022-00862
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)250912(10)C1977699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G34109
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1977699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2022
• Event Location: Hospital
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1