BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 22487491 · Received July 11, 2025

    Report

    Report Number
    2124215-2025-45061
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: THE EVENT DATE WAS NOT REPORTED. THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS ENTERED AS AN ESTIMATE. G4: PREMARKET / 510(K) # K173820, K213593.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: THE EVENT DATE WAS NOT REPORTED. THE FIRST DATE OF THE MONTH OF THE AWARE DATE WAS ENTERED AS AN ESTIMATE. G4: PREMARKET / 510(K) # K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE TELESCOPE, SHEATH, AND IMAGING WINDOW WERE KINKED. ALSO, THE GUIDEWIRE WAS FOUND TO BE ENTANGLED WITH THE IMAGING WINDOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WRAPPED AROUND THE UNKNOWN WIRE, MAKING IT IMPOSSIBLE TO REMOVE THE IVUS CATHETER WITHOUT ALSO REMOVING THE INTERVENTIONAL WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WRAPPED AROUND THE UNKNOWN WIRE, MAKING IT IMPOSSIBLE TO REMOVE THE IVUS CATHETER WITHOUT ALSO REMOVING THE INTERVENTIONAL WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838907 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035769648 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown