BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? HD

    MDR report key: 22376528 · Received July 1, 2025

    Report

    Report Number
    2124215-2025-43754
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960737
    PMA / PMN Number
    K173284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT REPORTED. G4: PREMARKET / 510(K)# - K173824, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT WAS ESTIMATED BASED ON AWARE DATE AS THE EVENT DATE WAS NOT REPORTED. G4: PREMARKET / 510(K)# - K173824, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE SHEATH WAS KINKED, AND THE GUIDEWIRE WAS NOT RETURN FOR ANALYSIS. THE GUIDEWIRE EXIT PORT, AND THE DISTAL SECTION OF THE TIP WERE IN GOOD CONDITION, WITH NO SIGNS OF TWISTING AROUND THE IMAGING WINDOW. A TEST GUIDEWIRE WAS INSERTED, AND THERE WAS NO INDICATION OF RESISTANCE WHEN TRACKING THE GUIDEWIRE INTO THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER GOT STUCK ON THE WIRE, TWISTED AND BROKE THE WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER GOT STUCK ON THE WIRE, TWISTED AND BROKE THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357860 OPTICROSS? HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939352040 0035211910 08714729960737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown