BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS

    MDR report key: 23531278 · Received November 12, 2025

    Report

    Report Number
    2124215-2025-79587
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 19, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729841531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED ON THE DEVICE. HOWEVER, A REVIEW OF MEDIA PROVIDED BY THE CUSTOMER SHOWED A CATHETER MISRECOGNITION ISSUE BUT DID NOT SHOW ENOUGH EVIDENCE TO IDENTIFY A DEVICE DEFECT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. THE PACKAGING INDICATED IT WAS AN OPTICROSS 40 MHZ CATHETER; HOWEVER, UPON CONNECTION, THE SYSTEM RECOGNIZED IT AS AN OPTICROSS 18 (30 MHZ) CATHETER INTENDED FOR PERIPHERAL USE. THE PROCEDURE WAS CONTINUED USING THE ORIGINAL DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WITH 80 - 90% STENOSED WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. THE PACKAGING INDICATED IT WAS AN OPTICROSS 40 MHZ CATHETER; HOWEVER, UPON CONNECTION, THE SYSTEM RECOGNIZED IT AS AN OPTICROSS 18 (30 MHZ) CATHETER INTENDED FOR PERIPHERAL USE. THE PROCEDURE WAS CONTINUED USING THE OPTICROSS 18, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934110 OPTICROSS CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8655 0035389454 08714729841531

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown