MAUDE Adverse Event Report: ASAHI INTECC FIELDER XT; GUIDE WIRE

Catalog Number	AGP140002
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Wire was knuckled and physician was trying to advance the wire but it would not go.When attempting to remove the wire, the tip broke off in the patient's artery.Broken tip was jailed with a stent.No adverse affect to the patient.

• Brand Name: FIELDER XT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20826594
• Report Number: 3004718255-2024-00343
• Device Sequence Number: 18593498
• Product Code: DQX
• UDI-Device Identifier: 04547327072854
• UDI-Public: (01)04547327072854(17)251231(10)230123A381
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024
• Report Date (Section F): 12/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: AGP140002
• Device Lot Number: 230123A381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2024
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/02/2024