MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO14 ES; GUIDE WIRE

Catalog Number	AP14R324S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sfa, popliteal, rt tibioperoneal trunk extending throughout rt post tibial artery.Contralateral placement of sheath to rt sfa completed and mongo14 es used as initial peripheral guide wire.After successfully navigating through sfa, popliteal and tibioperoneal trunk and most of the rt post tib.Wire advancement was stopped, crosswalk advanced and mongo wire was removed with the intent to try another wire to advance.Upon review of wire post removal, the tip of the wire excluding the core was stripped from the wire.Upon angiographic review, the tip of wire was left in the distal posterior tibial artery at the beginning of the cto.The physician and i discussed the finding and he stated that it would cause no further harm to the patient because of the existing cto.

• Brand Name: GLADIUS MONGO14 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: 19727324
• Report Number: 3004718255-2024-00331
• Device Sequence Number: 20884675
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)270228(10)240311A441
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/24/2024
• Report Date (Section F): 07/12/2024

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: 240311A441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 69 KG
• Date Report Sent to FDA: 07/12/2024