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

Catalog Number RMS-060024-R

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient went to hospital for the stent follow up check , and user checked the stent in patient with ct while found out the wire inside the stent stick out and tightly attached to the ureter.User removed the cook rms stent from patient and placed another brand (b)(4) stent."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

• 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: 17734641
• MDR Text Key: 323249421
• Report Number: 3001845648-2023-00698
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)250818(10)C1970063
• Combination Product (y/n): N
• 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
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1970063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2023
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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