BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 22790451 · Received August 12, 2025

    Report

    Report Number
    2124215-2025-56085
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN AN ABORTED PROCEDURE. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PREPARATION, THE CATHETER COULD NOT SHOW THE IMAGE, HOWEVER THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79532 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0036586095 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown