BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITRACK ADVANCE

    MDR report key: 19915726 · Received August 6, 2024

    Report

    Report Number
    3005641545-2024-00018
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    June 21, 2024
    Report Date
    August 6, 2024
    Manufacturer
    NOVA EYE, INC.
    Product Code
    MPA
    PMA / PMN Number
    K221872
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PRODUCTION RECORDS SHOW LOT# 2404-10 WAS BUILT USING APPROVED MATERIALS AND RELEASE PROCEDURES WERE CARRIED OUT BY A TRAINED OPERATOR. NO ANOMALIES WERE REPORTED IN THE PRODUCTION RECORD. THE SURGEON USED NORMAL WELL UNDERSTOOD PROCESSES TO INTRAOPERATIVELY REMOVE THE CATHETER SHEATH. THE SURGEON USED AN ALTERNATIVE PROCEDURE TO COMPLETE THE GLAUCOMA TREATMENT. THIS DID NOT RESULT IN ADDITIONAL RISK TO THE PATIENT. GATT IS A SURGICAL PROCEDURE TO REDUCE THE PATIENT IOP AND INVOLVES DISRUPTION OF THE TRABECULAR MESHWORK. DISRUPTION OF THE TRABECULAR MESHWORK IS ROUTINELY CARRIED OUT AS PART OF CANALOPLASTY PROCEDURES WITH THE ITRACK ADVANCE. 'TRABECULAR MESHWORK RUPTURE' IS CURRENTLY LISTED IN THE PRODUCT INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT.

    Description of Event or Problem · 0

    THE OUTER TUBING OF THE CATHETER BROKE AWAY FROM THE MAIN DEVICE DURING USE. THE SURGEON USED A SPATULA TO REMOVE THE DETACHED CATHETER PARTS FROM THE PATIENT'S EYE. AS A RESULT OF THE DEVICE BREAKAGE, THE SURGEON ALTERNATIVELY PERFORMED A 90 DEGREE GATT TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770179 ITRACK ADVANCE CANALOPLASTY MICROCATHETER KIT WITH ADVANCED DELIVERY SYSTEM MPA NOVA EYE, INC. ITRACK-ADS 2404-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention