BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 18858322 · Received March 7, 2024

    Report

    Report Number
    2024168-2024-02924
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 7, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO INDICATION OF A LOT-SPECIFIC PRODUCT QUALITY ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED FAULTY PRESSURE REGISTRATION AND FRAYED TIP COIL. IT MAY BE POSSIBLE THAT DURING INSERTION OR REMOVAL, THE TIP COIL WAS CAUGHT BY ACCESSORY DEVICES (SUCH AS AN INTRODUCER NEEDLE, ETC) OR ANOTHER CATHETER WHICH COULD RESULT IN THE REPORTED FRAYED TIP COIL. IT MAY ALSO BE POSSIBLE THAT THE WIRE WAS INADVERTENTLY DAMAGED SUCH AS BEND/KINK WHICH MAY CAUSE AN ELECTRICAL ISSUE AND AFFECT THE READING RESULTING IN THE REPORTED PRESSURE REGISTRATION ISSUE. HOWEVER, WITHOUT HAVING THE DEVICE EXAMINED, THESE COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE PRESSUREWIRE X WIRELESS (PWX) HAD AN ABNORMAL EQUALIZATION VALUE. THE ATRIAL PRESSURE HAD AN EQUALIZATION DIFFERENCE OF 35 ON THE FIRST TRY, AND 63 ON SECOND ATTEMPT. AFTER THE PWX WAS REMOVED, THE TIP WAS NOTED TO BE FRAYED. ANOTHER PWX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE ISSUE OCCURRED IN LAB 3. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745814 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 30801G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown