BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE¿

    MDR report key: 22470964 · Received July 10, 2025

    Report

    Report Number
    2024168-2025-07097
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    July 4, 2025
    Report Date
    September 11, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    DXO
    UDI-DI
    05415067025715
    PMA / PMN Number
    K180558
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY TO ADVANCE WAS NOT ABLE TO BE CONFIRMED DUE TO THE OPERATIONAL CONTEXT OF THE REPORTED ISSUE; HOWEVER, 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 DIFFICULTY TO ADVANCE AND MATERIAL SEPARATION WHICH RESULTED IN DEVICE EMBEDDED IN TISSUE, OBSTRUCTION, ANGINA, AND UNEXPECTED MEDICAL INTERVENTION APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THE RETURNED DEVICE WAS NOTED TO BE KINKED AND BENT THROUGHOUT, WHICH IS CONSISTENT WITH BOTH CAUSING AND BEING CAUSED BY THE REPORTED DIFFICULTY TO ADVANCE; HOWEVER, THE DISTAL TUBE, MICROCABLES AND COREWIRE WERE ALL SEPARATED AT THE SAME LOCATION WHICH IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE GUIDEWIRE, TYPICALLY DURING WITHDRAWAL, AND IS UNRELATED TO THE REPORTED DIFFICULTY TO ADVANCE. IN THIS CASE, IT IS LIKELY THAT PATIENT¿S ANATOMICAL CONDITION (TIGHT LESION) CAUSED THE REPORTED DIFFICULTY TO ADVANCE AND THE USE TECHNIQUES EMPLOYED CAUSED THE OBSERVED MATERIAL SEPARATION. 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. D4: LOT NUMBER CORRECTED FROM UNKNOWN TO 50404G1, D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4), H6: HEALTH EFFECT - CLINICAL CODE 2687 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRESSUREWIRE X(PWX), WIRELESS DEVICE WAS TO BE USED IN THE OBTUSE MARGINAL (OM) WITH SIGNIFICANT CALCIFICATION AND TORTUOSITY. DURING THE PROCEDURE, THE PWX FRACTURED INTO TWO PIECES. THE DISTAL FRAGMENT COULD NOT BE RETRIEVED AND REMAINS INSIDE THE PATIENT. FOLLOWING THE INCIDENT, A STENT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: RESISTANCE WAS FELT DURING ADVANCEMENT DUE TO THE TIGHT LESION. THE TIP OF THE PWX FRACTURED AND IS NOT FREE FLOATING IT IS ENTRAPPED BY THE IMPLANTED STENT. THE PATIENT EXPERIENCED CHEST PAIN AND FLOW DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730040 PRESSUREWIRE¿ TRANSDUCER, PRESSURE, CATHETER TIP DXO LIGHTLAB IMAGING, INC. C12059 50404G1 05415067025715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention