BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 21766817 · Received April 3, 2025

    Report

    Report Number
    2124215-2025-19657
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET/510(K) #: K173284, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE IVUS CATHETER WAS TESTED PRIOR TO INSERTION, THE IMAGE DISPLAYED NON-UNIFORM ROTATIONAL DISTORTION (NURD), AND A KINK WAS FOUND IN THE CATHETER. IT WAS FURTHER NOTED THAT THE CATHETER WAS FRACTURED/SEPARATED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575319 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0035310567 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown