BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSUREWIRE¿

    MDR report key: 20570808 · Received October 30, 2024

    Report

    Report Number
    2024168-2024-12755
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 22, 2024
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION WAS ABLE TO BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE 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 THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED MATERIAL SEPARATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE BENDS AND KINKS TO THE GUIDEWIRE WERE THE CAUSE FOR THE CONFIRMED MATERIAL SEPARATION. IN THIS CASE, IT IS LIKELY THAT THE BENDS AND KINKS WERE CAUSED BY THE USE TECHNIQUES EMPLOYED, OR THE PATIENT ANATOMICAL CONDITIONS. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION 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 THAT THE PRESSUREWIRE X, WIRELESS (PWX) DEVICE WAS USED IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) LESION AND THE READINGS WERE SUCCESSFULLY OBTAINED. AFTER THE PWX WAS REMOVED IT WAS NOTED THAT THE DISTAL END HAD SEPARATED. THE PWX DID NOT FULLY BREAK INTO TWO PIECES UNTIL IT WAS NEAR THE COPILOT. THE WIRE WAS FOUND TO BE FRACTURED ONCE IT WAS INSIDE THE PROXIMAL PORTION OF THE GUIDE CATHETER NEAR THE COPILOT (AND ALMOST OUTSIDE OF THE PATIENT'S BODY ENTIRELY). THE SEPARATED SEGMENT OF THE WIRE WAS REMOVED MANUALLY. THERE WAS NO RESISTANCE DURING REMOVAL OF THE PWX. THERE WAS NO DEVICE ISSUE WITH THE COPILOT. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961235 PRESSUREWIRE¿ CATHETER TIP PRESSURE TRANSDUCER DXO LIGHTLAB IMAGING, INC. C12059 40619G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown