BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRACK ADVANCE

    MDR report key: 19988214 · Received August 14, 2024

    Report

    Report Number
    3005641545-2024-00022
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 15, 2024
    Manufacturer
    NOVA EYE, INC.
    Product Code
    MPA
    UDI-DI
    00893872001622
    PMA / PMN Number
    K221872
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    UPON COMPLETION OF THE CANALOPLASTY PROCEDURE, THE DEVICE WAS HANDED TO THE SCRUB TECH WHO PUSHED THE ACTUATOR FORWARD WHILE SETTING IT ASIDE. THIS WAS OBSERVED BY A NOVA EYE, INC. MEDICAL AFFAIRS REPRESENTATIVE PRESENT AT THE SURGERY. THE NEI REP. NOTICED THAT THE DISTAL SECTION OF THE CATHETER LOOKED SLIMMER THAN NORMAL AND ASKED TO INSPECT THE DEVICE. UPON INSPECTION, THE DISTAL SECTION OF THE CATHETER SHEATH WAS IDENTIFIED AS BEING SEPARATED FROM THE MID-SECTION. THE REP IMMEDIATELY INFORMED THE SURGEON THAT A PORTION OF THE CATHETER WAS MISSING FROM THE DEVICE AND RECOMMENDED THE ANGLE BE CHECKED. THE SURGEON THOROUGHLY INSPECTED THE ANGLE WITH A GONIO PRISM FROM MULTIPLE ANGLES AND FOUND NO FOREIGN BODY IN THE PATIENT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164215 ITRACK ADVANCE CANALOPLASTY MICROCATHETER KIT WITH ADVANCED DELIVERY SYSTEM MPA NOVA EYE, INC. ITRACK-ADS 2404-25 00893872001622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown