BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 15883165 · Received November 29, 2022

    Report

    Report Number
    2024168-2022-12017
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 6, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THE DEVICE WAS REPORTEDLY DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ADDITIONAL DRAGONFLY OPTIS DEVICE IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR), CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB (CATSWEB) DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO REMOVE. IT MAY BE POSSIBLE THAT THE USER¿S TECHNIQUE WHEN REMOVING THE DRAGONFLY OVER THE GUIDEWIRE MAY HAVE CONTRIBUTED TO THE INADVERTENT INTERACTION BETWEEN THE DEVICES, RESULTING IN THE REPORTED DIFFICULT TO REMOVE; HOWEVER, THIS COULD NOT BE CONFIRMED. 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 DRAGONFLY OPTIS IMAGING CATHETER AND THE PRESSUREWIRE X, WIRELESS (PWX) DEVICE WERE INTENDED TO BE USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION WITH MILD CALCIFICATION AND TORTUOSITY. THE PWX DEVICE WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. HOWEVER, THE DISTAL MARKER OF THE IMAGING CROSSED INTO THE RADIOPAQUE PORTION OF THE PWX DEVICE. THEREFORE, THE IMAGING CATHETER WAS REMOVED, BUT THEN THE RADIOPAQUE PORTION OF THE PWX DEVICE HAD LOOPED AROUND THE IMAGING CATHETER RESULTING IN THE PWX DEVICE TO BE REMOVED ALONG WITH IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526337 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown