MAUDE Adverse Event Report: GAIA SECOND; GUIDE WIRE

Model Number	AHW14R008P
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dr (b)(6) said while trying to cross left main lesion the tip of the gaia 2nd was engaged in lesion and not moving.The tip may have been trapped in heavy calcium and would not move forward, he started to remove wire which did not come out easily and may have broke or separated at tip.Prior in the case he said a raider wire also broke.Dr (b)(6) used several wires during case and was able to cross lesion with astato 20 and fielder xt.Because of angle of vessel he was not able to treat lesion with balloon/stent or any other treatment device.No part of wire was left in patient, and md states patient was stable with no complications at end of case.

• Brand Name: GAIA SECOND
• Common Device Name: GUIDE WIRE
• MDR Report Key: 12625633
• Report Number: 3004718255-2021-00238
• Device Sequence Number: 4165487
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)240229(10)210313A181
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/12/2021
• Report Date (Section F): 10/13/2021

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: 02/29/2024
• Device Model Number: AHW14R008P
• Device Catalogue Number: AHW14R008P
• Device Lot Number: 210313A181
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/12/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 10/13/2021