BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 23531709 · Received November 12, 2025

    Report

    Report Number
    2124215-2025-82087
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K): K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED TARGET LESION. THE OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THERE WAS NO DIFFICULTY ADVANCING TO POSITION, BUT THERE WAS DIFFICULTY ADVANCING IN THE POPLITEAL. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED TO BE BENT AND TWISTED. THE DEVICE WAS REPLACED AND THE PROCEDURE COMPLETED WITH NO FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122275 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036977953 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown