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	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lumiguide wire was used in a complex fevar procedure with four fenestrations.The cannulation of the superior mesenteric artery (sma) was difficult, resulting in few attempts with different catheters.During the final angiogram, a dissection was noted in the sma, but was covered with stents.The dissection seemed to originate more distal than where the lumiguide was ever used; thus, likely occurred during manipulation of a catheter in combination with a terumo wire; however, cannot be certain.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.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Block a3b: 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 france.Block g2: study name is lumiguide radfree.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.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 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: 24512704
• Report Number: 3042175841-2026-10501
• Device Sequence Number: 21442634
• 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: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026
• Report Date (Section F): 03/04/2026

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: 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: 02/10/2026
• Device Age: 6 MO
• Date Report to Manufacturer: 03/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• 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: 7F, TOURGUIDE STEERABLE SHEATH.; COOK: 5F, KMP100 GUIDE CATHETER.; COOK: 5F, RIM100 GUIDE CATHETER.; CORDIS: 4F, USL2 100 GUIDE CATHETER.; GORE: 18F, DRYSEAL FLEX INTRODUCER SHEATH.; PHILIPS: LUMIGUIDE EQUIPMENT CONSOLE.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 03/04/2026