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

Model Number	AP14R324S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Mongo wire coating on the tip of the wire became unraveled and dislodged into a branch of the r posterior tibial artery.

• 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: 13481830
• Report Number: 3004718255-2022-00249
• Device Sequence Number: 1779675
• Product Code: DQX
• UDI-Device Identifier: 04547327123747
• UDI-Public: (01)04547327123747(17)240531(10)210602A011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2022
• Report Date (Section F): 02/08/2022

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: 05/31/2024
• Device Model Number: AP14R324S
• Device Catalogue Number: AP14R324S
• Device Lot Number: 210602A011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/20/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 128 KG
• Date Report Sent to FDA: 02/08/2022