MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

As initially reported to customer relations: i [district manager] was made aware yesterday evening of a product complaint pertaining to a resonance metallic stent at mease countryside hospital.Additional information: 10mar2023.The procedure was a stent removal- ureter.When the physician went to remove the stent, he noticed it was encrusted, and that a small wire from the stent was sticking into patient urter.Nothing was left in the patient.Extensive time to remove, patient was reported to come back for observation due to pain management.

Manufacturer Narrative

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

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• 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: 16628336
• MDR Text Key: 312410629
• Report Number: 3001845648-2023-00190
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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