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

Catalog Number	AGP140302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Wire became caught on the end of the support catheter and fractured a piece of the wire inside the tibial artery.Provider believed more damage would be done trying to get the piece of wire out.Wire was left in place with normal flow around it.

• 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: 19383675
• Report Number: 3004718255-2024-00329
• Device Sequence Number: 15221895
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)260731(10)230803A211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/23/2024
• Report Date (Section F): 05/23/2024

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: 07/31/2026
• Device Catalogue Number: AGP140302
• Device Lot Number: 230803A211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2024
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 05/23/2024