BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS¿ HD

    MDR report key: 25276584 · Received May 26, 2026

    Report

    Report Number
    25276584
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 14, 2026
    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

    THE IVUS CATHETER LOST THE IMAGE WHILE IN THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH NO REPORTED HARM. VENDOR NOTIFIED. MANUFACTURER RESPONSE FOR CORONARY IMAGING CATHETER BAGLESS, 5FR OPTICROSS 60 MHZ HD CORONARY IMAGING CATHETER BAGLESS (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417248 OPTICROSS¿ HD TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX BOSTON SCIENTIFIC CORPORATION H74939352050 38451826

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other