BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMIGUIDE NAVIGATION WIRE 3D ULTRA

    MDR report key: 25072552 · Received May 4, 2026

    Report

    Report Number
    3042175841-2026-10507
    Event Type
    Death
    Date Received
    May 4, 2026
    Date of Event
    March 24, 2026
    Report Date
    May 4, 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
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCK A3B, A5 & A6: NOT AVAILABLE FROM FACILITY. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS H3: THE LUMIGUIDE WIRE WAS NOT RETURNED, THUS NO PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: PER THE COMPLAINT DETAILS, THE USER'S TECHNIQUE POSSIBLY CAUSED OR CONTRIBUTED TO THE PATIENT INJURY, RESULTING IN DEATH. PERFORATIONS DURING THIS KIND OF PROCEDURE IS A KNOWN RISK AND 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 IN A FOUR-VESSEL PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) PROCEDURE. DURING USE, THERE WERE NO SIGNS OF BLEEDING (POSSIBLY DUE TO AN ARTERIAL SPASM TEMPORARILY LIMITING OR OBSCURING THE BLEEDING), AND WHEN THE PATIENT LEFT THE OR, HE WAS IN STABLE CONDITION. HOWEVER, OVERNIGHT INTO THE NEXT MORNING, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND SWELLING, SUSPECTING A LEAK (PERFORATION), THUS REQUIRED EMERGENCY SURGERY. ON ANGIO, CONTRAST WAS POOLING TO THE RIGHT SUPERIOR MESENTERIC ARTERY (SMA), WHICH APPEARED TO BE EMANATING FROM A PROXIMAL BRANCH. THEREFORE, AN EXPLORATION OF MESENTERIC HEMATOMA WITH LIGATION OF BLEEDING BRANCHES AT THE ROOT AND A LIMITED TRANSVERSE COLECTOMY WERE PERFORMED. THEN, THE PATIENT WAS TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT (SICU) ON PRESSORS AND ONGOING RESUSCITATION; UNFORTUNATELY, THE PATIENT EXPIRED THREE DAYS LATER ON (B)(6) 2026. FURTHER INFORMATION PROVIDED BY THE PHYSICIAN STATES, THE VESSEL DAMAGE COULD HAVE BEEN CAUSED BY THE LUMIGUIDE WIRE, CATHETER, OR AMPLATX WIRE, BUT IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE. ADDITIONALLY, THE PHYSICIAN USED A MODIFIED STENT GRAFT THAT WAS NOT AN OPTIMAL MATCH FOR THE PATIENT¿S ANATOMY, WHICH RESULTED IN LESS FAVORABLE ALIGNMENT, CREATING A MORE CHALLENGING ANGLE FOR THE CATHETER AND SHEATH, AND DIRECTING TOWARDS THE AFFECTED VESSEL MAY HAVE CONTRIBUTED TO AN INCREASES MECHANICAL INTERACTION WITH THE VASCULATURE. THIS ADVERSE EVENT IS BEING SUBMITTED BECAUSE THE LUMIGUIDE WAS IN USE WHEN THE PERFORATION OCCURRED, REQUIRING INTERVENTION BUT RESULTING IN DEATH. THERE WAS NO ALLEGED MALFUNCTION WITH THE LUMIGUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391788 LUMIGUIDE NAVIGATION WIRE 3D ULTRA WIRE, GUIDE, CATHETER DQX PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LGN35160A3DU 10118884 00884838111110

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death AMPLATZ WIRE, MFG AND SIZE UNK.| MEDTRONIC: 7F, TOURGUIDE INTRODUCER SHEATH.| MERIT: 4F, BRN GUIDE CATHETER.| PHILIPS: LUMIGUIDE EQUIPMENT CONSOLE.