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 Code	Perforation of Vessels (2135)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lumiguide wire was used in an aortic aneurysm repair procedure.While navigating to the celiac artery, a perforation occurred.The lumiguide was removed and exchanged for a different wire.A stent was placed to treat the perforation, with no more bleeding observed.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.

• 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 ; +011(316)18706997
• MDR Report Key: 50213290
• Report Number: 3042175841-2026-10512
• Device Sequence Number: 6122777
• 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: 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: Voluntary
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026
• Report Date (Section F): 08/11/2026

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
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2026
• Device Age: 10 MO
• Date Report to Manufacturer: 08/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 5F Guide Catheter, Mfg Unk; Cook: 7F, Introducer Sheath; Philips: LumiGuide Equipment
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 125 LB
• Patient Race: White
• Date Report Sent to FDA: 10/02/2026