MAUDE Adverse Event Report: ASAHI INTECC CO., LTD FIELDER XT; GUIDEWIRE

Catalog Number	AGP140302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intra vascular lithotripsy with the wire alongside of the shockwave balloon.After stent placement in the lad they noticed the wire tip was behind the stent.They post dilated the stent, and the wire tip was stented into the vessel.There were no patient problems during or post procedure.The wire went to risk management team it will not be available for return.

• Brand Name: FIELDER XT
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 22378331
• Report Number: 3004718255-2025-00386
• Device Sequence Number: 11923379
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861(17)271130(10)241128A211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/01/2025
• Report Date (Section F): 07/01/2025

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 Catalogue Number: AGP140302
• Device Lot Number: 241128A211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2025
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/01/2025