BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 24821584 · Received April 8, 2026

    Report

    Report Number
    2024168-2026-01435
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    February 24, 2026
    Report Date
    April 8, 2026
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND ADDITIONAL TESTING METHODS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED COMMUNICATION ISSUE WAS CONFIRMED DUE TO AN OPEN CIRCUIT. THE REPORTED DIFFICULTY REMOVING THE PRESSUREWIRE FROM THE DISPENSER COIL WAS UNABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE AND THE ORIGINAL DISPENSER COIL WAS NOT RETURNED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED ONE RELATED COMPLAINT ASSESSMENT CAPA. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED ONE OTHER SIMILAR COMPLAINT RELATED TO THE CAPA. ALTHOUGH THE REPORTED DIFFICULTY REMOVING FROM THE DISPENSER COIL WAS UNABLE TO BE CONFIRMED, A POTENTIAL PRODUCT QUALITY ISSUE HAS BEEN IDENTIFIED RELATED TO DIFFICULTY REMOVING THE PRESSUREWIRE FROM THE DISPENSER COIL; THEREFORE, A CAPA HAS BEEN INITIATED. THE REPORTED COMMUNICATION PROBLEM APPEARS TO BE DUE DAMAGE TO THE INTERNAL COMPONENTS CAUSING THE NOTED OPEN CIRCUIT. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    REPORTEDLY, TWO PRESSUREWIRE X (PWX) WIRELESS DEVICES (51122G1) WERE USED DURING THE PROCEDURE. THE FIRST PWX WAS DIFFICULT TO REMOVE FROM THE HOOP DURING PREPARATION. AFTER REMOVAL FROM THE HOOP, THE DEVICE WAS CALIBRATED AND EQUALIZATION WAS SUCCESSFUL. AFTER EQUALIZATION, THERE WAS NO GREEN PRESSURE CURVE PRESENT, AND THE TRANSMITTER WAS GREEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE CONTINUED WITH THE SECOND DEVICE. THE SECOND PWX DEVICE COULD NOT BE EQUALIZED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT A REPLACEMENT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DURING PRODUCT RETURN INVESTIGATION, THE DISTAL TUBE HAD CUTS AND TEARING OF THE POLYIMIDE TUBING ALONG ITS ENTIRE LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341102 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 51122G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown