BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 22726039 · Received August 6, 2025

    Report

    Report Number
    2124215-2025-54639
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    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 PMA/510(K): K160514, K222568.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE IMAGING WINDOW WAS BENT. MICROSCOPE INSPECTION CONFIRMED THE BENT IMAGING WINDOW AND SHOWED THAT THE GUIDEWIRE EXIT PORT WAS LIFTED, WHILE THE DISTAL SECTION OF THE TIP REMAINED IN GOOD CONDITION. FUNCTIONAL TESTING WITH A TEST GUIDEWIRE SHOWED NO INDICATION OF RESISTANCE WHEN TRACKING THE GUIDEWIRE INTO THE CATHETER. G4 PMA/510(K): K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED FOR A LEG ANGIOGRAM. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND NON-TORTUOUS VESSEL. THE OPTICROSS 18 IMAGING CATHETER WAS PREPPED AND INSERTED NORMALLY FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING RECORDING/PULLBACK, THE CATHETER AND WIRE BECAME WRAPPED AND HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND WITH ANOTHER GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED FOR A LEG ANGIOGRAM. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND NON-TORTUOUS VESSEL. THE OPTICROSS 18 IMAGING CATHETER WAS PREPPED AND INSERTED NORMALLY FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING RECORDING/PULLBACK, THE CATHETER AND WIRE BECAME WRAPPED AND HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND WITH ANOTHER GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765800 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0035871905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT SPARTACORE GUIDEWIRE| ABBOTT SPARTACORE GUIDEWIRE