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	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Uncomplicated ce/abic with itrack advance (no trabeculotomy).The insertion and initial circumnavigation was smooth without any intracanalicular obstructions.While withdrawing and viscodilating, the sliding mechanism stopped and the withdrawal seemed to halt.This was after about 4-5 clock hours.Then, it suddenly released with an audible and tactile snap.The surgeon withdrew the microcatheter, noting the catheter sheath had snapped off relatively close to the hub and the black guidewire was visible.The remainder of the outer sheath was retained in the canal.The surgeon retrieved this using microforceps.
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: 20919412
• Report Number: 3005641545-2024-00055
• Device Sequence Number: 20100858
• Product Code: MPA
• UDI-Device Identifier: 00893872001622
• UDI-Public: 00893872001622
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 08/06/2025
• Device Model Number: ITRACK-ADS
• Device Catalogue Number: 203000-0001
• Device Lot Number: 2408-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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