BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 16265186 · Received January 30, 2023

    Report

    Report Number
    2024168-2023-00946
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 16, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED BREAK WAS NOT CONFIRMED THERE WAS NO CORE SEPARATION AS REPORTED. THE REPORTED STRETCH WAS CONFIRMED AS THE DISTAL COILS WERE FOUND TO BE STRETCHED 1MM PROXIMAL TO THE DISTAL TIP. THE CORE WAS BENT 1MM DISTAL TO THE SENSOR. THERE WERE MULTIPLE BENDS THROUGHOUT THE PROXIMAL WIRE CORE. 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 OTHER SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, THE INVESTIGATION DETERMINED THAT THE REPORTED STRETCH WAS DUE TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT, DURING DEVICE PREPARATION, THE DEVICE WAS INADVERTENTLY STRETCHED AT THE DISTAL END. ADDITIONALLY, A BREAK COULD NOT BE CONFIRMED AND WAS NOT OBSERVED DURING THE RETURNED ANALYSIS. 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 THE PRESSUREWIRE X (PWX) WIRELESS CONNECTED AND EQUALIZED SUCCESSFULLY. WHEN THE PWX WAS IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY, IT WAS NOTED THAT THE TIP WAS FRAYED AND STRETCHED OUT. THE CORE SEPARATED BUT THE GUIDE WIRE WAS HELD TOGETHER BY TIP COILS A NEW PWX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070044 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 20621G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown