BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 23053021 · Received September 15, 2025

    Report

    Report Number
    2024168-2025-09816
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    January 30, 2025
    Report Date
    September 15, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION, FUNCTIONAL AND ELECTRICAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION PROBLEM WAS CONFIRMED. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED COMMUNICATION OR TRANSMISSION PROBLEM WAS DUE TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT THE SEVERE KINKS AT THE PROXIMAL TUBE WHICH WAS RETURNED SEPARATED CAUSED DAMAGE TO THE MICRO CABLES RESULTING IN THE REPORTED COMMUNICATION PROBLEM AND NOTED OPEN CIRCUIT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSUREWIRE X WIRELESS (PWX) COULD NOT CONNECT TO THE SYSTEM. THE PAL LIGHTING COLOR PATTERN AT THE MOMENT OF THE FAILURE WAS BLINKING YELLOW AND GREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT USE OF ANOTHER PWX. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE PROXIMAL TUBE (PTFE COATING AREA) WAS SEPARATED BUT HELD TOGETHER BY THE COREWIRE 22 CENTIMETERS (CM) DISTAL TO THE PROXIMAL END OF THE PRESSUREWIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956079 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 40123G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown