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

Model Number IT-250A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Eye Injury (1845)

Event Date 05/12/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 317301704
• Report Number: 3005641545-2023-00001
• Device Sequence Number: 1
• Product Code: MPA
• UDI-Device Identifier: 00893872001059
• UDI-Public: (01)00893872001059(17)250301(10)230308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male