BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 21405848 · Received February 18, 2025

    Report

    Report Number
    2124215-2025-09113
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 29, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K173820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # - K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION FOUND THAT THE SHEATH WAS KINKED. MICROSCOPE INSPECTION CONFIRMED THAT THE GUIDEWIRE EXIT PORT WAS IN GOOD CONDITION, BUT A SMALL FRAGMENT OF THE DISTAL SECTION OF THE TIP WAS DETACHED. A FUNCTIONAL TEST WAS CONDUCTED WITH A TEST GUIDEWIRE, AND NO RESISTANCE WAS NOTED WHEN TRACKING THE GUIDEWIRE INTO THE CATHETER.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING A POST-STENT RUN, WHILE THE DEVICE WAS OUTSIDE THE PATIENT, THE DOCTOR NOTICED A SMALL FOREIGN OBJECT ON THE END OF THE CATHETER, WHICH WAS NOT PRESENT BEFORE THE FIRST IVUS RUN. THE OBJECT EASILY DETACHED FROM THE CATHETER AND EVERYTHING APPEARED INTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER OPTICROSS HD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING A POST-STENT RUN, WHILE THE DEVICE WAS OUTSIDE THE PATIENT, THE DOCTOR NOTICED A SMALL FOREIGN OBJECT ON THE END OF THE CATHETER, WHICH WAS NOT PRESENT BEFORE THE FIRST IVUS RUN. THE OBJECT EASILY DETACHED FROM THE CATHETER AND EVERYTHING APPEARED INTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER OPTICROSS HD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571995 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035118410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown