MAUDE Adverse Event Report: Philips Medical System 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 Code	Vascular Dissection (3160)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lumiguide wire was used in a fenestrated and branched endovascular repair procedure.The procedure was completed with no patient injury; however, during post-op ct, a possible dissection was noted where the lumiguide was used in.The patient is fine, and was discharged from the hospital as expected.This adverse event is being submitted because the lumiguide was used in the vessel, where a possible dissection occurred.There was no alleged malfunction with the lumiguide wire.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is spain.Blocks h3: the lumiguide wire was discarded, thus no product investigation was performed.Block h6: dissections during this kind of procedure are a known risk and are covered by the device risk management.Additionally, the device history record (dhr) was reviewed and all released units were manufactured to specification, with no ncrs or deviations contributing to the reported complaint.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.

• Brand Name: LumiGuide Navigation Wire 3D Ultra
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): Philips Medical System 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 ; +011(316)18706997
• MDR Report Key: 50064138
• Report Number: 3042175841-2026-10511
• Device Sequence Number: 18732286
• Product Code: DQX
• UDI-Device Identifier: 00884838111110
• UDI-Public: (01)00884838111110(11)250923(17)260923(10)10154766
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026
• Report Date (Section F): 07/28/2026

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: 09/23/2026
• Device Model Number: LGN35160A3DU
• Device Catalogue Number: LGN35160A3DU
• Device Lot Number: 10154766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/02/2026
• Device Age: 9 MO
• Date Report to Manufacturer: 07/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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: Guide Catheter, Mfg and Size Unk; Introducer Sheath, Mfg and Size Unk; Philips: LumiGuide Equipment
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/24/2026