MAUDE Adverse Event Report: ASAHI INTECC CO LTD ASAHI GLADIUS MONGO 14 ES; PERIPHERAL VASCULAR GUIDE WIRE

Model Number	AP14R324S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous peripheral intervention (ppi) was performed for a heavily calcified lesion at the origin of the peroneal artery.The lesion was crossed with an asahi gladius mongo 14 es guide wire.After the gladius mongo 14 es guide wire was removed for wire exchange, peeling of the polymer jacket was observed, and the new guide wire could not be advanced.The device system was then removed and the procedure was restarted.It was informed that there were no adverse patient effects associated with this event and the patient was stable after the procedure.Mfr report #: (b)(4).

• Brand Name: ASAHI GLADIUS MONGO 14 ES
• Common Device Name: PERIPHERAL VASCULAR GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 25891167
• Report Number: 3004718255-2026-00029
• Device Sequence Number: 21323931
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)281231(10)260108A161
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/17/2026
• Report Date (Section F): 07/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AP14R324S
• Device Lot Number: 260108A161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2026
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/21/2026