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

Model Number	AP14R023S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mongo was advanced into the pro xs 150 through septal collateral.Xs tip was positioned into the subintimal space in prox rca.Physician had wire knuckled, upon removal of knuckle the tip of the mongo wire broke off.

• 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: 17205953
• Report Number: 3004718255-2023-00300
• Device Sequence Number: 15101056
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)260131(10)230131A031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2023
• Report Date (Section F): 06/26/2023

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: 01/31/2026
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Device Lot Number: 230131A031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/08/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Date Report Sent to FDA: 06/26/2023