BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 22399162 · Received July 3, 2025

    Report

    Report Number
    2124215-2025-42360
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 10, 2025
    Report Date
    August 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K222568.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K222568. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE IMAGING WINDOW WAS KINKED. MICROSCOPIC INSPECTION REVEALED THE GUIDEWIRE EXIT PORT WAS LIFTED BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. THE FUNCTIONAL TEST SHOWED A TEST GUIDEWIRE WAS INSERTED, AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WRAPPED AROUND WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND NEEDED TO BE REMOVED ENTIRELY. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OPTICROSS 18 IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WRAPPED AROUND WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE AND NEEDED TO BE REMOVED ENTIRELY. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803311 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036163135 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown