BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 21453286 · Received February 24, 2025

    Report

    Report Number
    2124215-2025-06705
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 23, 2025
    Report Date
    April 11, 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) #(CONT.): K160514, K222568. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A KINK WAS OBSERVED ON THE TIP. MICROSCOPIC INSPECTION REVEALED THAT THE GUIDEWIRE EXIT PORT WAS DAMAGED. IT WAS DEFORMED/LIFTED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. THE REPORTED GUIDEWIRE ENTANGLEMENT CAN BE CONFIRMED SINCE THE EXIT PORT DAMAGE AND KINKED TIP COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. CATHETER TESTED OUTSIDE BODY AND PREPPED AS NORMAL. UPON TURNING ON TO IMAGE AFTER POSITIONING, THE CATHETER TWISTED ON THE NON-BOSTON SCIENTIFIC WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. CATHETER TESTED OUTSIDE BODY AND PREPPED AS NORMAL. UPON TURNING ON TO IMAGE AFTER POSITIONING, THE CATHETER TWISTED ON THE NON-BOSTON SCIENTIFIC WIRE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414456 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0035278929

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown