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 No Code Available (3191)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a bilateral metallic stent exchange, one of the indwelling stents were difficult to remove.A scope was placed for viewing and it was noted that there is what appears to be a stone on the pigtail of the stent.A traditional polymer plastic stent was placed along side to create drainage until the indwelling stent issue can be addressed.The patient will require another procedure to deal with the stone and removal of indwelling metal and additionally placed plastic stent.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10641178
• MDR Text Key: 210370683
• Report Number: 3005580113-2020-00420
• 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: 10/06/2020,10/07/2020

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
• Distributor Facility Aware Date: 09/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2020
• 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