BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 22572178 · Received July 22, 2025

    Report

    Report Number
    2124215-2025-47760
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K173820, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER RECOGNITION ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE LESION. DURING PREPARATION, THE IVUS INTRAVASCULAR CORONARY CATHETER WAS INCORRECTLY REGISTERED AS A PERIPHERAL CATHETER ON THE AVVIGO II SYSTEM. THE USER PROCEEDED TO OBTAIN MEASUREMENTS USING THE CATHETER BUT WAS UNABLE TO VISUALIZE ARTERIAL DETAILS CLEARLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724649 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown