BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 6 HD

    MDR report key: 20785196 · Received November 26, 2024

    Report

    Report Number
    2124215-2024-73549
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 5, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K) # K213593

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS 6 HD CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, WHEN THE DEVICE WAS PLUGGED IN, IT WAS RECOGNIZED AS AN OPTICROSS 18. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569821 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0034445379 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown