BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 18143085 · Received November 15, 2023

    Report

    Report Number
    2024168-2023-12710
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    September 27, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, FUNCTIONAL, AND ELECTRICAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED EVENT OF FLASHING YELLOW/GREEN LIGHTS WAS CONFIRMED. THE DEVICE FAILED TO CALIBRATE AND IT DISPLAYED THE REPORTED LIGHT PATTERN. ELECTRICAL TESTING WAS PERFORMED AND IT REVEALED THAT THERE WAS A WET INSULATION ERROR ON THE GUIDEWIRE. IT WAS ALSO NOTED THAT THERE WAS A TEAR ON THE DISTAL TUBE WHICH MAY CAUSE THE INSULATION ERROR. IT WAS ALSO NOTED THAT THERE WERE MULTIPLE BENDS ON THE PROXIMAL TUBE; HOWEVER, THIS IS LIKELY DUE TO HANDLING DURING THE PROCEDURE. 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 DETERMINED THAT THE REPORTED FLASHING GREEN/YELLOW LIGHT IS LIKELY DUE TO THE NOTED INSULATION ERROR WHICH IS LIKELY CAUSED BY THE NOTED TEAR ON THE DISTAL TUBE. IT IS POSSIBLE THAT DURING PREPARATION, THE DISTAL TUBE WAS INADVERTENTLY TORN DUE TO INTERACTION WITH ANOTHER DEVICE RESULTING IN AN INSULATION ERROR AND THE REPORTED ISSUE. THE INSULATION ERROR MAY RESULT IN UNSTABLE PRESSURE READINGS DURING CALIBRATION; AS A RESULT, IT WOULD TRIGGER THE LIGHT PATTERN AS REPORTED. 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 WHEN CONNECTING THE PRESSUREWIRE X (PWX) TO THE COROVENTIS SYSTEM, THE TRANSMITTER BLINKS YELLOW AND GREEN. ANOTHER PWX WAS NOT ATTEMPTED. NO PATIENT WAS INVOLVED. DEVICE ANALYSIS FOUND THE DISTAL TUBE OF THE RETURNED PRESSUREWIRE X WAS TORN 3CM PROXIMAL TO THE SENSOR JACKET FOR APPROXIMATELY 3MM. THERE WAS REPORTEDLY NO POST PROCEDURE MANIPULATION OF THE WIRE BY THE SITE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319992 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 30615G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown