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	Perforation of Vessels (2135)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an aortic therapeutic procedure, an altatrack guidewire was used in a severely tortuous angulated celiac artery with median arcuate ligament compression.During use, resistance was encountered when trying to pass the curve; thus, the guidewire was removed, and a conventional equipment was tried to cannulate the vessel.After, angiography was performed, and contrast extravasation was visible.Therefore, the artery was plugged/coiled, and a cuff was placed inside the stent graft to occlude the perforation.The patient was stable with no further intervention required.This adverse event is being submitted because the altatrack guidewire was in use when a perforation occurred, requiring additional intervention.There was no alleged malfunction with the altatrack guidewire.
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.The altatrack guidewire was discarded, thus no returned product evaluation was performed.Perforations during this kind of procedure are a known risk and are covered by the device risk management.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 ; 31643215596
• MDR Report Key: 21903093
• Report Number: 3003768277-2025-10501
• Device Sequence Number: 8821740
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)251230(10)9447505
• 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: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2025
• Report Date (Section F): 04/24/2025

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: 12/30/2025
• Device Model Number: ATG35120A
• Device Catalogue Number: ATG35120A
• Device Lot Number: 9447505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2025
• Device Age: 3 MO
• Date Report to Manufacturer: 04/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2024
• 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: 14F INTRODUCER SHEATH, MFG UNK; CONSOLE: ALTATRACK EQUIPMENT; COOK: 5F GUIDE CATHETER
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Date Report Sent to FDA: 04/24/2025