BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS HD

    MDR report key: 21719302 · Received March 28, 2025

    Report

    Report Number
    2124215-2025-19193
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WAS INSERTED WITHOUT COMPLICATIONS. HOWEVER, UPON REMOVAL, THE MONORAIL PROLAPSED ON THE WIRE. BOTH THE WIRE AND CATHETER WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2699623 OPTICROSS HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0035364008 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown