MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Catalog Number RMS-060022-R

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Common device name: fad stent, ureteral.(b)(4).

Event Description

According to the initial reporter the stents had been in-dwelling for 12 months.The stents were encrusted so badly that they had to try 5 fr catheters, dual lumen catheters and a rigid cystoscope to dilate.Lastly they had to balloon dilate to remove the stents with flexible graspers.The balloon dilation of the ureters successfully removed the stents.The occluded wire of the second stent snapped and the stent turned into a slinky but was successfully removed.They did not have consent from the patient's guardian for percutaneous techniques.Further information provided states: stents were placed (b)(6) 2019.Patient had a couple ct scans for urinary tract infections, but due to covid the 6 month change was delayed to 12 months due to patient caregiver¿s decision.The physician has not heard from the patient and expects them to be doing well.It is mentioned "they did not have consent from the patient's guardian for percutaneous techniques." percutaneous consent wasn¿t provided at the time of the extraction procedure.However, following the stent extraction consent was obtained.The patient was then hospitalized overnight and perc¿ed the next morning for neph tube placement.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10703847
• MDR Text Key: 212311161
• Report Number: 3005580113-2020-00432
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2020,10/20/2020

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-060022-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2020
• 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
• Patient Age: 27 YR