MAUDE Adverse Event Report: Asahi Intecc CO Ltd ASAHI Gladius Mongo 14 ES; Peripheral Vascular Guide Wire

Model Number	AP14R324S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi gladius mongo 14 es guide wire was used during a plain old balloon angioplasty (poba) to treat a heavily calcified, heavily tortuous chronic total occlusion (cto) in the mid anterior tibial artery (ata).The ata was totally occluded throughout its entire length from the proximal segment.The gladius mongo 14 es guide wire was advanced into the proximal ata.While advancing the tip of the guide wire to make a small j shape, it got caught and entangled, forming a knot in one of the side branches of the ata branching off the proximal segment.Subsequently, the entangled portion of the guide wire could not be unknotted and withdrawn.The tip of the gladius mongo 14 es guide wire broke off within the small side branch of the ata.After the tip fracture, the proximal segment of the gladius mongo 14 es guide wire was successfully withdrawn from the patient anatomy.The separated wire tip remained in the patient anatomy and could not be retrieved.The physician commented that the tip of the guide wire became entangled and formed a knot as a result ofrapid advancement and rotation of the wire within an extremely narrow side branch of the ata.The size of the knot was presumed to be less than 3 mm.It was informed that there were no adverse patient effects associated with this event and the patient was discharged after the procedure.

• 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: 50722714
• Report Number: 3004718255-2026-00038
• Device Sequence Number: 18719367
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)290131(10)260202A111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 260202A111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• 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: Disability
• Patient Age: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/10/2026