BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 18012910 · Received October 26, 2023

    Report

    Report Number
    2024168-2023-11886
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    October 4, 2023
    Report Date
    March 5, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. BASED ON THE REPORTED INFORMATION, THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES WERE RELATED TO PROCEDURAL CIRCUMSTANCES. BASED ON THE REPORTED INFORMATION, THE REPORTED SIGNAL DRIFT WAS LIKELY THE RESULT OF DAMAGE TO THE MICRO CABLES DUE TO THE REPORTED KINK AND WHEN ATTEMPTING TO STRAIGHTEN THE KINK, THE WIRE SEPARATED. THE KINK WAS LIKELY DUE TO ANATOMICAL CONDITIONS DURING ADVANCEMENT/POSITIONING. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D9, H3 - DEVICE RETURNING STATUS UPDATED FROM YES TO NO.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS (PWX) WAS TO BE USED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS EQUALIZED IN THE AORTA, HOWEVER, A NON-ABBOTT DEVICE CAUSED PRESSURE DUMPING [DRIFT] WHEN IN LEFT MAIN (LM) LESION. A KINK WAS NOTED. THE PWX WAS JUST AT THE TIP OF CATHETER WHEN PRESSURE WAS LOST, AND THE SHAFT BROKE; THE COIL WAS ELONGATED. THE TIP OF THE PWX WAS TRAPPED WITH A BALLOON AND REMOVED TOGETHER WITH A NON-ABBOTT DEVICE AND A SION BLUE WIRE. ANOTHER PWX WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567294 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention