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

Catalog Number	AP14R324S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Wire broke off in calcified r sfa.

• 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: 15192171
• Report Number: 3004718255-2022-00268
• Device Sequence Number: 12240978
• Product Code: DQX
• UDI-Device Identifier: 14547327123744
• UDI-Public: (01)14547327123744(17)250228(10)220305A271
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/09/2022
• Report Date (Section F): 08/09/2022

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: 02/28/2025
• Device Catalogue Number: AP14R324S
• Device Lot Number: 220305A271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/19/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• 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: Male
• Patient Weight: 81 KG
• Patient Race: White
• Date Report Sent to FDA: 08/09/2022