BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 14380863 · Received May 12, 2022

    Report

    Report Number
    2024168-2022-05201
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 24, 2022
    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
    SN
    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. ADDITIONALLY, A REVIEW OF THE PROVIDED STILL IMAGE AND OCT VIDEO WERE REVIEWED BY AN ABBOTT CLINICAL RESEARCH & DEVELOPMENT ADVISOR. THE STILL FRAME ANGIOGRAPHY IMAGE SHOWS A RADIOLUCENT TIP OF THE PRESSUREWIRE X WIRE IN THE LAD. THE ATTACHED OCT VIDEO DID NOT CORRELATE WITH CORRESPONDING ANGIOGRAPHY IMAGE. A DEVICE MALFUNCTION WAS CONFIRMED VIA THE STILL FRAME IMAGE PROVIDED. A PROBABLE CAUSE OF THE MALFUNCTION COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED. THE REPORTED DIFFICULTY TO REMOVE WAS NOT ABLE TO BE CONFIRMED WITH THE RETURNED DEVICE AS IT WAS BASED ON CIRCUMSTANCES OF THE PROCEDURE. THE REPORTED SEPARATION WAS CONFIRMED ON THE RETURNED DEVICE. 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 WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DIFFICULTY ADVANCING AND SUBSEQUENT SEPARATION RESULTING IN UNEXPECTED MEDICAL INTERVENTION TO EMBED THE SEPARATED PORTION OF THE PRESSUREWIRE TIP. IT MAY BE POSSIBLE THAT DURING ADVANCEMENT OF THE PRESSUREWIRE FOR POST ASSESSMENT, THE TIP OF THE WIRE BECAME CAUGHT WITHIN THE NEWLY IMPLANTED STENT (POSSIBLY WITHIN THE STENT STRUTS) RESULTING IN SEPARATION. 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 THE PROCEDURE WAS PERFORMED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE PRESSUREWIRE X, WIRELESS (PWX) DEVICE WAS INSERTED, AND FRACTIONAL FLOW RESERVE (FFR) WAS SUCCESSFULLY PERFORMED. THE PWX WAS REMOVED, AND A STENT WAS IMPLANTED. THE PWX WAS REINSERTED FOR POST ASSESSMENT, BUT DURING ADVANCEMENT, THE TIP OF THE PWX BECAME CAUGHT ON THE IMPLANTED STENT AND SEPARATED. THEREFORE, THE PRESSUREWIRE WAS REMOVED, AND A SNARE WAS INSERTED. HOWEVER, THE TIP OF THE PWX WAS UNABLE TO BE RETRIEVED, SO THE PHYSICIAN DECIDED TO IMPLANT ANOTHER STENT OVER THE FIRST STENT TO TRAP THE WIRE TIP. AN OPTICAL COHERENCE TOMOGRAPHY (OCT) RUN WAS PERFORMED, AND IT WAS CONFIRMED THE TIP OF THE WIRE WAS BETWEEN THE TWO IMPLANTED STENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935354 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR X 11104G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention IMPLANTED STENT.