BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 19264132 · Received May 7, 2024

    Report

    Report Number
    2024168-2024-05591
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    February 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. THE INVESTIGATION DETERMINED THE CAUSE FOR THE REPORTED FAILURE TO ADVANCE AND MATERIAL SEPARATION WAS DUE TO OPERATIONAL CONTEXT. THE DAMAGE TO THE GUIDEWIRE OCCURRED FROM THE REPORTED INTERACTION BETWEEN THE STENT AND GUIDEWIRE¿CAUSING THE REPORTED FAILURE TO ADVANCE. WHILE THE GUIDEWIRE WAS ATTEMPTED TO BE WITHDRAWN, THE GUIDEWIRE BECAME SEPARATED AT THE DISTAL TIP¿CAUSING THE REPORTED MATERIAL SEPARATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H3 - CORRECTION: IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    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 FAILED TO ADVANCE THROUGH THE IMPLANTED STENT. THE TIP OF THE PWX GOT STUCK IN THE STENT DURING ADVANCEMENT AND THE TIP SEPARATED IN TWO PIECES. THE SEPARATED TIP WAS RETRIEVED WITH A SNARE DEVICE. A NEW PWX WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670943 PRESSUREWIRE¿ CATHETER TIP PRESSURE TRANSDUCER DXO LIGHTLAB IMAGING, INC. C12059 30818G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention