BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 21721118 · Received March 28, 2025

    Report

    Report Number
    2124215-2025-17508
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 1, 2025
    Report Date
    March 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING THE PROCEDURE, WHEN USING IVUS IT WRAPPED AROUND THE NON-BOSTON SCIENTIFIC GUIDEWIRE, AND THEY HAD TO TAKE EVERYTHING OUT OF THE BODY AND START OVER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614187 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0034900747 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown