MAUDE Adverse Event Report: ASAHI INTECC GAIA SECOND; GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Mongo was attempted without success, so a gaia second was used to navigate through the isr cto.When the wire reached the distal cap, the wire was torqued multiple times to advance down the distal vasculature but the tip would not respond.When retracting the wire, the core of the wire came out but the tip did not retract with the wire.Spring coil was attached to the mamba microcatheter.Catheter and wire tip were removed together.No fragments left behind.

• Brand Name: GAIA SECOND
• 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: 11283079
• Report Number: 3004718255-2021-00198
• Device Sequence Number: 3440548
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)230331(10)200401X021
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 01/29/2021
• Report Date (Section F): 02/04/2021

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: AHW14R008P
• Device Lot Number: 200401X021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/29/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2021
• 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: 02/04/2021