BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 23280442 · Received October 15, 2025

    Report

    Report Number
    2124215-2025-70313
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    PMA / PMN Number
    K160514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K160514, K222568

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% OR MORE STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS, SEVERELY CALCIFIED TIBIAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS ADVANCED OVER A V18 CONTROL WIRE. NO IMAGE APPEARED WHEN IMAGING WAS TURNED ON DURING PULLBACK AND IT WAS NOTED THAT THE CATHETER WAS WRAPPED ON ITSELF. THE DEVICE WAS REMOVED AND EVALUATED AT WHICH TIME SPIRAL COILING OF THE TIP OF THE CATHETER WAS NOTICED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174937 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036868131 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male V-18? CONTROLWIRE? GUIDEWIRE