BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 22572176 · Received July 22, 2025

    Report

    Report Number
    2124215-2025-47932
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 26, 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
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) # K173820, K213593. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE BATCH/LOT NUMBER IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. DURING THE PROCEDURE, THE PHYSICIAN MANUALLY PULLED BACK THE CATHETER WHILE IMAGING. DURING THIS PROCESS, AN UNKNOWN WIRE BECAME WRAPPED AROUND THE 6FR OPTICROSS HD CATHETER. BOTH WIRE AND THE CATHETER WERE REMOVED FROM THE PATIENT DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL METHOD. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724647 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown