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
After the fracture and removal of the 1st mongo es pre-shaped wire dr.(b)(6) asked for a 2nd mongo es pre-shaped wire (which came out of the same box with the same lot#) and he inserted it down to the distal pt where he again was unable to navigate the tortuosity and cross the lesion.When he removed the wire he again notified me that the 2nd mongo es pre-shape wire had fractured and separated from the polymer jacket like the 1st one.

• 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: 11576321
• Report Number: 3004718255-2021-00209
• Device Sequence Number: 19879284
• 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): Unknown
• 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