BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS 6 HD

    MDR report key: 18852739 · Received March 6, 2024

    Report

    Report Number
    2124215-2024-13296
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    January 23, 2024
    Report Date
    March 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH 5150876 THAT REMOVAL DIFFICULTY OCCURRED RESULTING IN COMPROMISED FLOW. THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LABORATORY (CATH LAB) DUE TO A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER FAILED TO CAPTURE IMAGES, AND BECAME DIFFICULT TO REMOVE, RESULTING IN COMPROMISED FLOW WITHIN THE PATIENTS LEFT ANTERIOR DESCENDING AND CIRCUMFLEX ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534596 OPTICROSS 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION 8669 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other