MAUDE Adverse Event Report: ASAHI INTECC, INC. SION BLUE; GUIDEWIRE

Model Number	AHW14R104S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was no harm to the patient.Asahi sion blue guidewire sheared off during the coronary case.The sheared portion of the wire was removed from the coronary artery.

• Brand Name: SION BLUE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC, INC.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 24088691
• Report Number: 3004718255-2026-00001
• Device Sequence Number: 12219351
• Product Code: DQX
• UDI-Device Identifier: 14547327133019
• UDI-Public: (01)14547327133019(17)280430(10)250510A08F
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/15/2026
• Report Date (Section F): 01/15/2026

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 Model Number: AHW14R104S
• Device Lot Number: 250510A08F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• 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: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/15/2026