MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Model Number	G34109
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: fad stent, ureteral.(b)(4).
Event or Problem Description
According to the initial reporter the device failed to drain the kidney that was placed in the right ureter (separate complaint) and the stent in the left ureter migrated down the ureter because of over dilation (subject of this report).Both stents were initially placed on (b)(6) 2020 and then removed on (b)(6) 2020 due to a perceived failure.The procedure following the incident was a simple stent exchange of both rms stents.The patient was reported to be stable.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10507153
• Report Number: 3005580113-2020-00408
• Device Sequence Number: 3546165
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)230304(10)C1713983
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2020
• Report Date (Section F): 09/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: G34109
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1713983
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 09/09/2020