MAUDE Adverse Event Report: COOK IRELAND LTD GEENEN SOF-FLEX PANCREATIC STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	GPSOS-SF-5-3
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The incorrect stent was inside packaging.The stent intended to be placed was a g49668 from lot number c1994025.However, the stent in the packaging has internal flanges (the product details are unknown at this time; the product is being returned for evaluation).The incorrect stent was removed, and the correct stent was placed without issue.No harm to the patient reported.

• Brand Name: GEENEN SOF-FLEX PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 17540340
• Report Number: 3005580113-2023-00106
• Device Sequence Number: 17787305
• Product Code: FGE
• UDI-Device Identifier: 10827002496689
• UDI-Public: (01)10827002496689(17)251101(10)C1994025
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023
• Report Date (Section F): 08/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: GPSOS-SF-5-3
• Device Lot Number: C1994025
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2023
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/14/2023