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

Model Number	AP14R023S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During cardiac catheterization, guide wire was fractured and unable to be retrieved from the small branch of the distal obtuse marginal (om) chronic total occlusion (cto).What was the original intended procedure?: impella cp percutaneous lvad insertion and removal.What problem did the user have (check all that apply): device failed (e.G.Broke, couldn't get it to work or stopped working).

• 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: 13983750
• Report Number: 3004718255-2022-00252
• Device Sequence Number: 5779667
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)240731(10)210816A361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2022
• Report Date (Section F): 04/01/2022

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: 07/31/2024
• Device Model Number: AP14R023S
• Device Catalogue Number: AP14R023S
• Device Lot Number: 210816A361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/21/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2022
• 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: Male
• Date Report Sent to FDA: 04/01/2022