BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23197051 · Received October 1, 2025

    Report

    Report Number
    2124215-2025-69607
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 12, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THE SHEATH WAS KINKED, THE IMAGING CORE WAS DAMAGED, AND THERE WERE RIPPLES IN THE IMAGING WINDOW. MICROSCOPIC INSPECTION REVEALED GUIDEWIRE EXIT PORT AND TIP DAMAGE. THE CATHETER WAS PROPERLY RECOGNIZED BY THE IMAGING SYSTEM WHEN PLUGGED INTO THE MOTOR DRIVE UNIT, AND NO CONNECTION ISSUES OR ERRORS WERE DETECTED DURING ITS TESTING. THE AUTO PULLBACK COULD NOT BE PERFORMED DUE TO THE DEVICE CONDITION.

    Additional Manufacturer Narrative · 0

    G4 PREMARKET / 510(K): K173820, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION. DURING THE PROCEDURE, THE CATHETER ROTATION LOCKED UP. THE CATHETER BECAME ENTANGLED WITH, AND WRAPPED AROUND, THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION. DURING THE PROCEDURE, THE CATHETER ROTATION LOCKED UP. THE CATHETER BECAME ENTANGLED WITH, AND WRAPPED AROUND, THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434954 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0036624684 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TERUMO RUNTHROUGH 0.014 GUIDEWIRE.