BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 22877106 · Received August 22, 2025

    Report

    Report Number
    2124215-2025-56782
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729847878
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K123621, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE UNKNOWN WIRE BECAME WRAPPED AROUND THE CATHETER AND GOT STUCK. THE ENTIRE ASSEMBLY WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619037 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H749518110 0036416055 08714729847878

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown