MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO 14; GUIDE WIRE

Catalog Number	AP14R023P
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon traversing through the circumflex artery, attempt was made to access and cross a proximal om2 cto.The gladius mongo 14 was supported with a turnpike microcatheter.These vessels were reported to be heavily calcified.The distal tip of the gladius mongo broke off in the intimal space of the om2.The gladius mongo was removed and the decision was made to attempt a rotoblator intervention.A roto wire was inserted and an atherectomy of the proximal disease was performed.The tip of the gladius mongo was left in the subintimal space with no injury to patient.Risk management was alerted to the event and they completed a med watch report.

• Brand Name: GLADIUS MONGO 14
• 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: 22520399
• Report Number: 3004718255-2025-00387
• Device Sequence Number: 8079401
• Product Code: DQX
• UDI-Device Identifier: 04547327123693
• UDI-Public: (01)04547327123693(17)271231(10)241224A181
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/16/2025
• Report Date (Section F): 07/16/2025

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: AP14R023P
• Device Lot Number: 241224A181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2025
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/16/2025