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

Catalog Number	AP14R023P
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Gladius mongo 14 with a turnpike microcatheter traversed thru diffuse proximal rca disease but was not successful in crossing proximal cap of cto.Gladius mongo tip broke off in the proximal cap and wire was removed.Attempts to cross the cto were made with a fielder xt and gaia but were unsuccessful.Decision was made to abort crossing the cto and leave tip in vessel.An angioplasty was performed in the proximal diffuse disease.A second gladius mongo 14 was used and also had a tip break.(i will create a separate report for this wire).

• 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: 22521881
• Report Number: 3004718255-2025-00388
• Device Sequence Number: 8560387
• Product Code: DQX
• UDI-Device Identifier: 04547327123693
• UDI-Public: (01)04547327123693(17)271031(10)241126A291
• 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: 241126A291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2025
• Device Age: 7 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: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 07/16/2025