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

Catalog Number	AP14R023S
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to cross a heavily calcified circumflex.Had difficulty crossing the eccentric organized calcium.Wire appeared to have the polymer jacket compromised due to the presence of the calcium.No remedial action taken.Wire and all pieces were removed from vessel and new wire was selected.Patient was not in need of remedial action from the device failure.

• 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: 22020903
• Report Number: 3004718255-2025-00379
• Device Sequence Number: 9504492
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)271130(10)241223A321
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/14/2025
• Report Date (Section F): 05/14/2025

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: AP14R023S
• Device Lot Number: 241223A321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• 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: 05/14/2025