MAUDE Adverse Event Report: NOVA EYE, INC. ITRACK ADVANCE; CANALOPLASTY MICROCATHETER KIT WITH ADVANCED DELIVERY SYSTEM

Model Number	ITRACK-ADS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The outer sheath of the itrack advance catheter separated from the main device during use.The surgeon performed an unplanned goniotomy to remove the separated material from schlemm's canal.The surgeon invertedly grabbed the iris with the forceps while doing so.

• Brand Name: ITRACK ADVANCE
• Common Device Name: CANALOPLASTY MICROCATHETER KIT WITH ADVANCED DELIVERY SYSTEM
• Manufacturer (Section D): NOVA EYE, INC.; 41316 christy street; fremont CA 94538
• Manufacturer (Section G): NOVA EYE, INC.; 41316 christy street; fremont CA 94538
• Manufacturer Contact: don watton ; 41316 christy street; fremont, CA 94538 ; 5102911305
• MDR Report Key: 20318048
• Report Number: 3005641545-2024-00040
• Device Sequence Number: 15373318
• Product Code: MPA
• UDI-Device Identifier: 00893872001622
• UDI-Public: 00893872001622
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/29/2025
• Device Model Number: ITRACK-ADS
• Device Catalogue Number: 203000-0001
• Device Lot Number: 2407-32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown