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	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a2 & a3b: date of birth and gender were 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.Blocks e1 & g2: country is belgium.Blocks h3 & h6: the lumiguide wire was discarded; thus, no product investigation was performed.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 an aortic procedure.The lumiguide was loaded with a non-philips guide catheter and inserted into a non-philips steerable sheath, then advanced to the right renal artery (raa).During cannulation of the rra, resistance was encountered at the curve.Checking with contrast, a dissection was noted, and was treated with the original planned procedure by bridging a stent.This adverse event is being submitted because the lumiguide was in use when a dissection occurred, requiring intervention.There was no alleged malfunction with the lumiguide.
Additional Manufacturer Narrative
Block h6: based on the additional information received from the facility, the physician gave control of the lumiguide wire to a less experienced user, that may caused or contributed to the dissection.Investigation conclusions code, d1102 (unintended use error caused or contributed to event) is included.In the initial mdr, investigation conclusions code, d12 (known inherent risk of device) was listed and remains appropriate.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 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: 24192718
• Report Number: 3003768277-2026-10502
• Device Sequence Number: 15831030
• Product Code: DQX
• UDI-Device Identifier: 00884838111110
• UDI-Public: (01)00884838111110(11)250820(17)260820(10)10116865
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K233853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026
• Report Date (Section F): 01/27/2026

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: 08/20/2026
• Device Model Number: LGN35160A3DU
• Device Catalogue Number: LGN35160A3DU
• Device Lot Number: 10116865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2026
• Device Age: 5 MO
• Date Report to Manufacturer: 01/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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: APTUS: TOURGUIDE STEERABLE SHEATH, SIZE UNK.; COOK: 20F, EXTRA LARGE CHECK-FLO INTRODUCER SHEATH.; PHILIPS: LUMIGUIDE EQUIPMENT.; TERUMO: 5F, NAVICROSS SUPPORT CATHETER.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 01/27/2026