MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI SION BLACK; WIRE, GUIDE, CATHETER

Model Number	APW14R010S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the guidewire fractured off and was unable to be retrieved.

• Brand Name: ASAHI SION BLACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave., suite 212; tustin CA 92780
• MDR Report Key: 23604344
• Report Number: 23604344
• Device Sequence Number: 15947176
• Product Code: DQX
• UDI-Device Identifier: 14547327089682
• UDI-Public: 14547327089682
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/11/2025
• Report Date (Section F): 11/11/2025

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 Model Number: APW14R010S
• Device Catalogue Number: APW14R010S
• Device Lot Number: 250408A06F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Date Report Sent to FDA: 11/11/2025