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

Model Number	ITRACK-ADS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-op, the patients' iop spiked and an ac washout and implant removal was carried out.When the high iop persisted, a drainage device was implanted.On the day of this implant procedure, a small piece of the itrack advance catheter sheath material was noticed by the surgeon at the otomy site and removed.

• Brand Name: ITRACK ADVANCE
• Common Device Name: CANALOPLASTY MICROCATHETER 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: 20502450
• Report Number: 3005641545-2024-00048
• Device Sequence Number: 8209790
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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 Model Number: ITRACK-ADS
• Device Catalogue Number: 203000-0001
• Device Lot Number: UNKNOWN
• 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: 09/26/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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