BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS¿ HD

    MDR report key: 23496211 · Received November 7, 2025

    Report

    Report Number
    23496211
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PREP, THE IVUS CATHETER WOULD NOT FLUSH. THE CATHETER WAS REMOVED AND REPLACED WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR INTRAVASCULAR ULTRASOUND CATHETER, 5FR OPTICROSS 60 MHZ HD CORONARY IMAGING CATHETER BAGLESS (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172071 OPTICROSS¿ HD TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC CORPORATION H74939352050 36967046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown