MAUDE Adverse Event Report: ASAHI INTECC SION BLUE; GUIDE WIRE

Catalog Number	AHW14R104S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Two sion blue wires were used.The wire that was placed in the distal segment of the lad was left prolapsed for about 15 minutes.When pulling the wire back it encountered calcium in the proximal segment of the lad and the tip broke off.A stent was placed to trap the fragment.
Additional Manufacturer Narrative
For #(b)(4), as the lot number was confirmed to be 240902a151 when the affected device was returned to aij after reporting to fda, i would like to submit a follow-up report to correct the lot number, expiration date and udi code.
Event or Problem Description
Two sion blue wires were used.The wire that was placed in the distal segment of the lad was left prolapsed for about 15 minutes.When pulling the wire back it encountered calcium in the proximal segment of the lad and the tip broke off.A stent was placed to trap the fragment.

• Brand Name: SION BLUE
• 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: 21554264
• Report Number: 3004718255-2025-00374
• Device Sequence Number: 4643095
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)270831(10)240902A151
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 04/17/2025
• Report Date (Section F): 03/07/2025

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: AHW14R104S
• Device Lot Number: 240902A151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/07/2025