MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Catalog Number RMS-060022-R

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Occlusion (1984)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Fad stent, ureteral.(b)(4).

Event Description

According to the initial reporter: a patient of unknown age and gender had a resonance stent implanted in a previous procedure.The physician was to remove the stent however the stent was calcified in the bladder and possibly in the kidney.The physician is to perform an eswl procedure in attempt to break up the calcification.The physician at the time of notification did not have the procedure scheduled.It was further reported: unable to remove stent, appeared encrusted distally in bladder, would no uncurl proximally.This is not her first metallic stent, prior one did fine for over a year.An eswl procedure is scheduled for the week of (b)(6) 2020.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9626802
• MDR Text Key: 188816629
• Report Number: 3005580113-2020-00111
• 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: 01/24/2020

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
• Date Report Sent to FDA: 01/24/2020
• Distributor Facility Aware Date: 01/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• 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: 74 YR
• Patient Weight: 104