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

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This wire was used to navigate a tortuous distal pt.Dr.(b)(6) was attempting to navigate the wire around a tight angle and was unsuccessful.When he removed the wire to use a different wire he noticed that the tip had fractured and the polymer jacket had separated and the inner core of the wire was exposed.Unfortunately another mongo es pre-shaped wire was pulled from the same box with the same lot# and that wire fractured in the same way at the same point of the angled, distal pt.

• Brand Name: GLADIUS MONGO 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: 11576149
• Report Number: 3004718255-2021-00208
• Device Sequence Number: 16915586
• Product Code: DQX
• UDI-Device Identifier: 14547327123751
• UDI-Public: (01)14547327123751(17)230331(10)200424A081
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/12/2021
• Report Date (Section F): 03/26/2021

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AP14R324P
• Device Lot Number: 200424A081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/26/2021