BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMIGUIDE NAVIGATION WIRE 3D ULTRA

    MDR report key: 24345616 · Received February 16, 2026

    Report

    Report Number
    3003768277-2026-10506
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    January 29, 2026
    Report Date
    May 22, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    DQX
    UDI-DI
    00884838111110
    PMA / PMN Number
    K233853
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK B6: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS E1 & G2: COUNTRY IS FRANCE. BLOCKS H3: THE LUMIGUIDE WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: PERFORATIONS DURING THIS KIND OF PROCEDURE ARE A KNOWN RISK AND ARE COVERED BY THE DEVICE RISK MANAGEMENT. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LUMIGUIDE WIRE WAS USED WITH A NON-PHILIPS GUIDE CATHETER IN AN AORTIC PROCEDURE. DURING CANNULATION OF THE INFERIOR MESENTERIC ARTERY, A PERFORATION WAS NOTED, AND WAS TREATED WITH A VASCULAR PLUG. THE PATIENT WAS DISCHARGED WITHOUT ADDITIONAL TREATMENT REQUIRED. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN A PERFORATION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623168 LUMIGUIDE NAVIGATION WIRE 3D ULTRA WIRE, GUIDE, CATHETER DQX PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LGN35160A3DU 10116865 00884838111110

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male APTUS: 7F TOURGUIDE STEERABLE SHEATH.| CORDIS: 5F BERN1 GUIDE CATHETER.| GORE: 14F DRYSEAL INTRODUCER SHEATH.| PHILIPS: LUMIGUIDE EQUIPMENT.