BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 22115303 · Received May 30, 2025

    Report

    Report Number
    2124215-2025-33982
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K): K173820, K213593.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE CATHETERIZATION LAB FOR AN INFERIOR WALL STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) AND HAD TWO STENTS PLACED IN RIGHT CORONARY ARTERY. THE IVUS WAS USED AFTERWARDS TO ENSURE THE STENTS WERE PROPERLY PLACED AND DEPLOYED IN THE CORONARY ARTERY. WHEN IVUS IMAGING WAS DONE THE CATHETER COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE GUIDEWIRE AT THE SAME TIME. IT APPEARS THAT IVUS CATHETER GOT STUCK ON THE WIRE. IVUS CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AS A SINGLE UNIT. NO HARM TO PATIENT BUT COULD HAVE POTENTIALLY CAUSED HARD IF A GUIDEWIRE WAS STILL NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35742 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0035686233 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention