MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALTATRACK GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	ATG35120A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an altatrack wire was used for an aortic procedure.During advancement of the altatrack and catheter, a dissection was noted in the right renal artery.Angioplasty was used to treat the dissection, and the procedure continued using conventional techniques.This adverse event is being submitted because the altatrack was in use when a dissection occurred.There was no alleged malfunction with the altatrack wire.
Additional Manufacturer Narrative
This complaint was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a6: not available from facility.Block b6 & b7: not available from facility.Block c: not applicable for this device.Blocks d4, f9 & h4: the lot number was not provided; thus, the following information is unknown: unique id, expiration date, approximate age of device, and manufacture date.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is united kingdom.Block h3: the altatrack was discarded, thus no returned product evaluation 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: ALTATRACK GUIDEWIRE
• 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 31618706997
• MDR Report Key: 24886830
• Report Number: 3042175841-2026-10506
• Device Sequence Number: 10460260
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)240726(10)7433648
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026
• Report Date (Section F): 04/15/2026

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: 07/26/2024
• Device Model Number: ATG35120A
• Device Catalogue Number: ATG35120A
• Device Lot Number: 7433648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2026
• Device Age: 7 MO
• Date Report to Manufacturer: 04/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2023
• 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: PHILIPS: ALTATRACK EQUIPMENT; UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/15/2026