MAUDE Adverse Event Report: NOVA EYE, INC. CANALOPLASTY MICROCATHETER KIT ITRACK 250A

Model Number	IT-250A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Cyclodialysis cleft formation during canaloplasty with itrack 250a microcatheter.Cleft repair was carried on the same day as a precaution to prevent hypotony.An mvr blade was used to make the goniotomy.During initial intubation of the schlemms canal with the microcatheter an obstruction was encountered within 1 clock hour of the goniotomy.The surgeon applied additional pressure to the microcatheter with microforceps, the obstruction could not be by-passed, however this resulted in a kink in the microcatheter and a 1 clock hour cyclodialysis cleft.Subsequently an attempt was made to intubate schlemms canal with the same microcatheter from the opposite direction.The microcatheter went into the cyclodialysis cleft and not schlemms canal.The surgeon then abandoned the canaloplasty, performed a cataract removal and repaired the cleft.The surgeon noted that the mvr blade could have caused a deeper opening in the wall of the schlemms canal, leading to increased likelihood of cleft formation.

• Brand Name: CANALOPLASTY MICROCATHETER KIT ITRACK 250A
• Common Device Name: ITRACK 250A
• 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 ; 5102911300
• MDR Report Key: 17141061
• Report Number: 3005641545-2023-00001
• Device Sequence Number: 7826156
• Product Code: MPA
• UDI-Device Identifier: 00893872001059
• UDI-Public: (01)00893872001059(17)250301(10)230308
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2025
• Device Model Number: IT-250A
• Device Catalogue Number: 200478
• Device Lot Number: 2303-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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 Age: 72 YR
• Patient Sex: Male