BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 22569131 · Received July 22, 2025

    Report

    Report Number
    2124215-2025-49245
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GOOD FAITH EFFORT ATTEMPTS ARE BEING MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION HAS NOT BEEN OBTAINED. G4 PMA/510(K): K173284, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PULLBACK, THE CATHETER BECAME TANGLED WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712771 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0035787205 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown