BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 18222056 · Received November 28, 2023

    Report

    Report Number
    2024168-2023-13147
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 6, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 REVEALED NO OTHER SIMILAR INCIDENTS. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTY TO REMOVE RESULTING IN SEPARATION WAS LIKELY RELATED TO PROCEDURAL CIRCUMSTANCES. IT WAS REPORTED THAT ANOTHER WIRE WAS USED WITH PRESSUREWIRE X AND THEY WERE REPORTED TO BECOME ENTANGLED. IT IS LIKELY THAT ONE OF THE WIRES WAS BENT/KINKED DURING ADVANCEMENT DUE TO THE CHALLENGING ANATOMICAL CONDITIONS; AS A RESULT, BOTH WIRES WERE ENTANGLED DURING USE WHICH LIKELY CAUSED THE REPORTED SEPARATION DURING WITHDRAWAL. 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 THE PROCEDURE WAS PERFORMED IN THE 85% STENOSED, HEAVILY TORTUOUS, AND MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LAD WAS SUCCESSFULLY CANNULATED. SUBSEQUENTLY, THE PRESSUREWIRE X WIRELESS (PWX) WAS INSERTED THROUGH THE GUIDING CATHETER TO THE DISTAL LAD. THE GUIDING CATHETER WAS THEN REMOVED FROM THE OSTIUM OF THE RIGHT CORONARY ARTERY. WHILE PULLING THE PWX BACK INTO THE GUIDING CATHETER, A J TIP WIRE WAS INSERTED INTO THE 3.5/6 FR JR GUIDING CATHETER. DURING WITHDRAWAL OF THE J TIP WIRE, THE PWX BECAME ENTANGLED WITH THE J TIP WIRE. WHEN ATTEMPTING TO PULL THEM APART, THE PWX SEPARATED AND REMAINED ATTACHED TO THE GUIDING CATHETER. THE PWX AND THE GUIDING CATHETER WERE REMOVED TOGETHER AS A UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553911 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 20106G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male GUIDE CATHETER: 3.5/6 FR| GUIDE WIRE: J TIP