BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 19212654 · Received April 30, 2024

    Report

    Report Number
    2024168-2024-05258
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 30, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL AND FUNCTIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAULTY PRESSURE REGISTRATION COULD NOT BE CONFIRMED DUE TO DEVICE CONDITIONS. CORROSION WAS NOTED ON BOTH THE RETURNED TRANSMITTER AND WIRE COMPONENTS WHICH LIKELY DUE TO LIQUID EXPOSURE DURING SHIPPING BACK TO ABBOTT; AS A RESULT, FUNCTIONAL TESTING COULD NOT BE PERFORMED. A BREAK WAS NOTED BETWEEN THE PROXIMAL AND DISTAL TUBES; HOWEVER, THEY ARE STILL HELD TOGETHER BY THE COREWIRE. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUES. THE INVESTIGATION DETERMINED THAT THE REPORTED FAULTY PRESSURE REGISTRATION IS LIKELY DUE TO THE NOTED BREAK. IN THIS CASE, IT IS LIKELY THAT INADVERTENT DAMAGE (RESULTING IN A BREAK BETWEEN PROXIMAL AND DISTAL TUBES) OCCURRED DUE TO EXCESSIVE FORCE OR MISHANDLING DURING USE. AS A RESULT, IT MAY HAVE CAUSED AN ELECTRICAL ISSUE INSIDE THE WIRE THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. BASED ON THE FINDINGS, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PRESSUREWIRE X, (PWX) WIRELESS FAILED TO EQUALIZE. IT IS SUSPECTED THE SENSOR IS NOT WORKING, THE PRESSURE CURVE WENT FROM FLAT TO INFINITY. AFTER SEVERAL FAILED ATTEMPTS TO EQUALIZE, A NEW PWX WAS USED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS OBSERVED A DISTAL TUBE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159996 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 30818G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown