BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 17041436 · Received June 1, 2023

    Report

    Report Number
    2024168-2023-05747
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    March 7, 2023
    Report Date
    June 13, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS, FUNCTIONAL TESTING, AND ELECTRICAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED EVENT OF FAULTY PRESSURE REGISTRATION COULD NOT BE CONFIRMED DUE TO DEVICE CONDITIONS. HOWEVER, THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED, BUT IT FAILED TO CALIBRATE. AN ELECTRICAL TEST WAS PERFORMED WHICH REVEALED THAT THERE WAS AN OPEN CIRCUIT ON THE PROXIMAL TUBE REGION. IT WAS NOTED THAT THE DISTAL TUBE WAS SEPARATED FROM THE TRANSITION TUBE, BUT STILL HELD TOGETHER BY THE COREWIRE. THE INVESTIGATION DETERMINED THAT THE REPORTED FAULTY PRESSURE REGISTRATION WAS LIKELY DUE TO THE NOTED OPEN CIRCUIT WHICH COULD BE CAUSED BY THE NOTED SEPARATION ON THE DISTAL TUBE. IT IS UNKNOWN WHAT CAUSED THE SEPARATION. IT MAY BE POSSIBLE THAT AN EXCESSIVE FORCE WAS USED DURING THE INSERTION/WITHDRAWAL OF THE DEVICE, OR THERE WAS AN INTERACTION BETWEEN PRESSUREWIRE WITH ANOTHER DEVICE DURING THE PROCEDURE WHICH COULD LEAD TO THE NOTED SEPARATION; HOWEVER, THIS COULD NOT BE CONFIRMED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE ANALYSIS AND RECEIVED INFORMATION, THE SEPARATION WAS STILL HELD TOGETHER BY THE COREWIRE, AND THERE WERE NO ADVERSE PATIENT EFFECTS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL PRESSUREWIRE X DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED CALIBRATION WAS SUCCESSFUL WITH THE TWO PRESSUREWIRE X (PWX) WIRELESS. HOWEVER, EQUALIZATION FAILED; THE PRESSURE SIGNAL DROPPED FROM TIME TO TIME. THE SAME ISSUE OCCURRED WITH THE TWO PWX, DURING USE. THE TRANSMITTER LIGHT AT THE TIME OF THE ISSUE IS UNKNOWN. THE DISTAL TUBE FOR BOTH PRESSUREWIRES WAS SEPARATED FROM THE TRANSITION TUBE, BUT STILL HELD TOGETHER BY THE COREWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33334 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 21010G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown