BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23782114 · Received December 11, 2025

    Report

    Report Number
    2124215-2025-90438
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K173820, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K173820, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE SHEATH ASSEMBLY WAS KINKED. MICROSCOPIC INSPECTION SHOWED THE GUIDEWIRE EXIT PORT, AND THE DISTAL SECTION OF THE TIP WERE IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER TIP BROKE WHILE ATTEMPTING AN INTRAVASCULAR ULTRASOUND IMAGING RUN. THE DEVICE WAS REMOVED IN ONE PIECE, AND AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER TIP BROKE WHILE ATTEMPTING AN INTRAVASCULAR ULTRASOUND IMAGING RUN. THE DEVICE WAS REMOVED IN ONE PIECE, AND AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553968 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0036716366 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown