MAUDE Adverse Event Report: ASAHI INTECC GLADIUS MONGO 14 ES; GUIDEWIRE

Catalog Number	AP14R324S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Md knuckled wire with in rca cto and upon removing jacketed portion came off core wire.The jacketed portion broke off in the subintimal space and was unretrievable.There was no side effects.They were unable to cross due to tough cto and the amount of radiation, so the second procedure was performed later.In the second procedure, the cto was crossed from retrograde approach and stented.

• Brand Name: GLADIUS MONGO 14 ES
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20207610
• Report Number: 3004718255-2024-00339
• Device Sequence Number: 18085050
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)250630(10)220709A061
• 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): 09/12/2024
• Report Date (Section F): 09/12/2024

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 Expiration Date: 06/30/2025
• Device Catalogue Number: AP14R324S
• Device Lot Number: 220709A061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• 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: 09/12/2024