MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LUMIGUIDE NAVIGATION WIRE 3D ULTRA; WIRE, GUIDE, CATHETER

Model Number	LGN35160A3DU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematoma (1884); Perforation of Vessels (2135)
Date of Event	03/24/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: LUMIGUIDE NAVIGATION WIRE 3D ULTRA
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: franka couwenberg ; veenpluis 6; best 5684 -PC ; NL 5684 PC ; 31618706997
• MDR Report Key: 25072552
• Report Number: 3042175841-2026-10507
• Device Sequence Number: 10407622
• Product Code: DQX
• UDI-Device Identifier: 00884838111110
• UDI-Public: (01)00884838111110(11)250903(17)260903(10)10118884
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026
• Report Date (Section F): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2026
• Device Model Number: LGN35160A3DU
• Device Catalogue Number: LGN35160A3DU
• Device Lot Number: 10118884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2026
• Device Age: 6 MO
• Date Report to Manufacturer: 05/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ WIRE, MFG AND SIZE UNK.; MEDTRONIC: 7F, TOURGUIDE INTRODUCER SHEATH.; MERIT: 4F, BRN GUIDE CATHETER.; PHILIPS: LUMIGUIDE EQUIPMENT CONSOLE.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Date Report Sent to FDA: 05/04/2026