BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICROSS 18

    MDR report key: 20711840 · Received November 18, 2024

    Report

    Report Number
    2124215-2024-68940
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729904366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION B3 - DATE OF EVENT: USED 10/01/2024 AS THE EVENT DATE WAS NOT REPORTED. G4 - PREMARKET / 510(K) #: K160514, K222568.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: USED 10/01/2024 AS THE EVENT DATE WAS NOT REPORTED. G4: PREMARKET/510(K) #: K160514, K222568.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE COULD NOT PROVIDE IMAGING BEYOND A GRAINY BACKGROUND SCREEN FROM THE BEGINNING. SUBSEQUENTLY, THE DEVICE EXPERIENCED A POWER OVERLOAD, CAUSING THE CATHETER TO WRAP AROUND THE GUIDEWIRE WHEN THE IMAGING WAS STOPPED. AN ATTEMPT TO UNPLUG AND RECONNECT TO THE MOTOR DRIVE UNIT (MDU) WAS PERFORMED, BUT THE ISSUE PERSISTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER OPTICROSS 18. MOREOVER, THE PATIENT WAS DOING WELL POST-PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE COULD NOT PROVIDE IMAGING BEYOND A GRAINY BACKGROUND SCREEN FROM THE BEGINNING. SUBSEQUENTLY, THE DEVICE EXPERIENCED A POWER OVERLOAD, CAUSING THE CATHETER TO WRAP AROUND THE GUIDEWIRE WHEN THE IMAGING WAS STOPPED. AN ATTEMPT TO UNPLUG AND RECONNECT TO THE MOTOR DRIVE UNIT (MDU) WAS PERFORMED, BUT THE ISSUE PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608886 OPTICROSS 18 CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H7493932800180 0033574958 08714729904366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown