BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 22566172 · Received July 22, 2025

    Report

    Report Number
    2124215-2025-48109
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: THE EVENT DATE WAS NOT REPORTED. THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS ENTERED AS AN ESTIMATE. G4: PREMARKET / 510(K) # K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THAT THE TELESCOPE WAS KINKED, AND THE IMAGING WINDOW WAS TWISTED. A BROKEN IMAGING CORE (IC), DRIVE, AND COAXIAL CABLE BEGAN 3.3 CM FROM THE DISTAL END OF THE CONNECTOR SHAFT. THE GUIDEWIRE EXIT PORT, AND THE DISTAL SECTION OF THE TIP WERE IN GOOD CONDITION. A TEST GUIDEWIRE WAS INSERTED, AND THERE WAS NO INDICATION OF RESISTANCE WHEN TRACKING THE GUIDEWIRE INTO THE CATHETER. THE UNIT WAS CUT TO INSPECT THE OTHER END OF THE BROKEN IC.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: THE EVENT DATE WAS NOT REPORTED. THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS ENTERED AS AN ESTIMATE. G4: PREMARKET / 510(K) # K173820, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSIS WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR POST-STENT ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, NO IMAGE WAS SHOWN. UPON ASSESSMENT, THE CATHETER APPEARED TWISTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSIS WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR POST-STENT ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, NO IMAGE WAS SHOWN. UPON ASSESSMENT, THE CATHETER APPEARED TWISTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803335 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035399117 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown