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

Catalog Number RMS-060026-R

Device Problem Complete Blockage (1094)

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

Event Date 03/01/2023

Event Type  Injury  

Event Description

Per complaint form: stent formed encrustation after 3 months in the patient.Initial reporter: "i¿ve heard back from the urologist, and she hasn¿t removed the stent yet.See response below." "are you supposed to be able to exchange the silicone stents less frequently? it still looks like every 3-4mo to me? we may just continue resonance and try to extend to 4-5mo.I'm hoping with a shorter stent, there would be less encrustation.I haven't removed the stent yet so i can't answer the questions that you have but we can answer once i arrange for stent removal and sending back." further information provided: "when we removed the stent, what appeared to be encrustation in the original picture, was soft and had a mucus texture.The stent was draining and working.(physician) went down a size and replaced the 26 cm stent with a 24 cm stent.In addition, i¿ve attached pictures of the stent.(i have the stent and i have shipped back on behalf of the customer.) i have the replacement stent, (g34111/26 cm) that was sent to the hospital and exchanged it for a 24 cm (g34110) stent that i had in my car stock.Both g34110 & g34111 have been sent back.(physician) is going to check the stent in 5 months.".

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 16706499
• MDR Text Key: 312940758
• Report Number: 3005580113-2023-00041
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2023,04/10/2023

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2023
• 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