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

Model Number	ITRACK-ADS
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Itrack advance device was inspected before entering the eye and confirmed as worked correctly.After cannulating 360 degrees, the surgeon started retracting the catheter.Around 180 degrees they noticed that it would not retract any further.At that point it separated, and the catheter had to be withdrawn from the eye with a pair of mst forceps.The surgeon delivered 180 degrees of viscoelastic before the separation.
Additional Manufacturer Narrative
Nova eye has completed the root cause investigation into the cause of recent reports of itrack advance catheter breakages and identified and implemented the required corrective actions.To date, these are confirmed as effective in preventing further catheter breakages.Nova eye will continue to monitor all product feedback to confirm the effectiveness of the actions taken.

• 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: 20920415
• Report Number: 3005641545-2024-00056
• Device Sequence Number: 5118626
• Product Code: MPA
• UDI-Device Identifier: 00893872001622
• UDI-Public: 00893872001622
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: 05/07/2025
• Device Model Number: ITRACK-ADS
• Device Catalogue Number: 203000-0001
• Device Lot Number: 2405-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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