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	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter broke near the spatulated tip during the gatt procedure using itrack advance.

• 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: 20273609
• Report Number: 3005641545-2024-00038
• Device Sequence Number: 17011675
• Product Code: MPA
• UDI-Device Identifier: 00893872001622
• UDI-Public: 00893872001622
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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: 08/01/2025
• Device Model Number: ITRACK-ADS
• Device Catalogue Number: 203000-0001
• Device Lot Number: 2407-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Patient Sex: Unknown