BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 22725921 · Received August 6, 2025

    Report

    Report Number
    2124215-2025-53979
    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: PREMARKET / 510(K) # K160514, K222568.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE IMAGING WINDOW AND TIP WERE KINKED. THE GUIDEWIRE EXIT PORT WAS LIFTED, BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. A TEST GUIDEWIRE WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER. G4: PREMARKET / 510(K) # K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE CATHETER WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE. BOTH THE CATHETER AND THE WIRE WERE PULLED OUT TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS PERIPHERAL IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE CATHETER WRAPPED AROUND A NON-BOSTON SCIENTIFIC (NON-BSC) WIRE. BOTH THE CATHETER AND THE WIRE WERE PULLED OUT TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725878 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0036356982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT SPARTACORE WIRE.| ABBOTT SPARTACORE WIRE.