BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23934348 · Received December 31, 2025

    Report

    Report Number
    2124215-2025-93946
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820,
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. 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 SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING AUTOMATIC PULLBACK, THE CATHETER SEIZED ON THE GUIDEWIRE AND THE WIRE WRAPPED UP INSIDE THE SHEATH OF THE OPTICROSS CATHETER. THE WHOLE SYSTEM WAS STUCK TOGETHER AND WAS REMOVED AS ONE UNIT. PROLONG THE PROCEDURE NO MORE IMAGING WAS NEEDED AND THE PROCEDURE CONTINUED TO COMPLETION. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708312 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown