BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 23128689 · Received September 23, 2025

    Report

    Report Number
    2124215-2025-66559
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    July 25, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K123621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH MW5174024 THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, UPON REMOVAL OF THE IVUS CATHETER, BOTH INTERVENTIONAL WIRES WERE SHEARED OFF. IN ADDITION, THE TIP OF A NON-BOSTON SCIENTIFIC GUIDEWIRE SNAPPED OFF AND BECAME LODGED IN THE IVUS CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580715 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H749518110 0036416055

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown POWERTURN WIRE - ABBOTT