BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARLIGHT IMAGING CATHETER

    MDR report key: 23591895 · Received November 19, 2025

    Report

    Report Number
    23591895
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    SPECTRAWAVE, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INTRAVASCULAR ULTRASOUND CATHETER STOPPED WORKING AFTER ONE USE. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER OF THE SAME LOT WITH THE SAME RESULT. A DIFFERENT LOT WAS USED WITH SUCCESS. MANUFACTURER RESPONSE FOR INTRAVASCULAR ULTRASOUND CATHETER, 2.5 FRENCH DUAL-MODALITY STARLIGHT IMAGING CATHETER (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873514 STARLIGHT IMAGING CATHETER SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO SPECTRAWAVE, INC. 951 100218 X 2 CATHETERS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown