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	Vascular Dissection (3160)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a5 & a6: not available from facility.Block b6: not available from facility.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block h3: the lumiguide was discarded, thus no returned product evaluation was performed.Block h6: aortic dissection is a known risk of complication with use of the lumiguide, 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 was used in a fevar procedure in a moderately calcified and tortuous left renal artery.Multiple stents were placed in conjunction with the fevar graft to provide a good seal zone of the renal artery and aorta.However, when cannulating with the lumiguide, a dissection was noted; therefore, an additional uncovered stent was placed distal to the freshly deployed stents in the renal artery.The case progressed as normal, and final angiogram showed better blood flow from the kidney to the left renal artery.This adverse event is being submitted because the lumiguide was in use when a dissection occurred, requiring additional intervention.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 ; 31643215596
• MDR Report Key: 22469232
• Report Number: 3003768277-2025-10502
• Device Sequence Number: 18127767
• Product Code: DQX
• UDI-Device Identifier: 00884838111110
• UDI-Public: (01)00884838111110(11)240627(17)250627(10)8958128
• 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): 07/10/2025
• Report Date (Section F): 07/10/2025

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: 06/27/2025
• Device Model Number: LGN35160A3DU
• Device Catalogue Number: LGN35160A3DU
• Device Lot Number: 8958128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Device Age: 1 YR
• Date Report to Manufacturer: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2024
• 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: ANGIODYNAMICS: 5F GUIDE CATHETER; BAYLIS STEERABLE SHEATH; GORE: 14F INTRODUCER SHEATH
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 07/10/2025