BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿ X GUIDEWIRE

    MDR report key: 19255861 · Received May 6, 2024

    Report

    Report Number
    2024168-2024-05553
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 9, 2024
    Report Date
    June 19, 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
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE AND DIFFICULT TO REMOVE COULD NOT BE TESTED AS IT WAS BASED ON PROCEDURAL CIRCUMSTANCES. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT, IT IS LIKELY THAT THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING, AND SEPARATION WERE DUE TO INTERACTION WITH THE NEWLY IMPLANTED STENT. REPORTEDLY, THE TIP OF PRESSURE WIRE BECAME STUCK WITH THE STENT STRUT RESULTING IN SEPARATION, UNEXPECTED MEDICAL INTERVENTION AND FOREIGN BODY LEFT IN PATIENT. BASED ON THE REPORTED INFORMATION AND EVALUATION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    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 THE PRESSUREWIRE X (PWX), WIRELESS WAS TO BE USED IN THE LEFT MAIN (LM),CIRCUMFLEX (CX) LESION, THE BIFURCATION WAS STENTED. WHEN ADVANCING THE PWX, RESISTANCE WAS FELT WITH THE IMPLANTED STENT STRUT AND THERE WAS DIFFICULTY REMOVING THE PWX DUE TO THE IMPLANTED STENT. THE PWX TIP SEPARATED IN THE ANATOMY DUE TO THE INTERACTION WITH THE STENT STRUT. THE TIP WAS ATTEMPTED TO BE RETRIEVED BY A SNARE DEVICE BUT WAS UNSUCCESSFUL. THE TIP REMAINS FREE FLOATING IN THE TIBIAL ARTERY. FRACTIONAL FLOW RESERVE WAS DISCONTINUED. THERE WAS NO PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599569 PRESSUREWIRE¿ X GUIDEWIRE CATHETER TIP PRESSURE TRANSDUCER DXO ABBOTT VASCULAR 31206G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention