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

Catalog Number	AP14R023S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Rathore attempted the mongo 14 through a corsair multiple times into the rca.Once he determined that we were not going to cross he engaged the svg.There was zero flow in the rca graph and 100% occluded.Physician attempted to probe mongo in to the svg and after two minutes the distal tip broke into the svg lesion.

• Brand Name: GLADIUS MONGO
• 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: 17804594
• Report Number: 3004718255-2023-00304
• Device Sequence Number: 7183310
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)260331(10)230330A051
• 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): 09/22/2023
• Report Date (Section F): 09/22/2023

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: 03/31/2026
• Device Catalogue Number: AP14R023S
• Device Lot Number: 230330A051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2023
• Device Age: 23 WK
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/22/2023