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

Catalog Number	AP14R324S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Mongo used via ulnar artery to attempt revascularization; wire was heavily torqued and "knotted up" in the distal ulnar artery.When attempting to remove the wire from the anatomy, part of distal coil detached from the proximal coil & was left in the body.

• Brand Name: GLADIUS MONGO 14 ES
• 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: 22092511
• Report Number: 3004718255-2025-00383
• Device Sequence Number: 6925980
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)271231(10)241224A201
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/27/2025
• Report Date (Section F): 05/27/2025

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: AP14R324S
• Device Lot Number: 241224A201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2025
• 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: 05/27/2025