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	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a peripheral therapeutic 4-fevar procedure, an altatrack guidewire was used with a non-philips angiographic catheter.During navigation, fluoroscopy confirmed a stable position in the middle of the vessel for a safe exchange to an interventional guidewire.Therefore, the altatrack guidewire was removed, but contrast medium unveiled a small dissection in the mid celiac artery trunk.The dissection was immediately closed successfully with a covered stent.No patient injury reported.This adverse event is being submitted because the altatrack guidewire caused a dissection, and required additional intervention.There was no alleged malfunction with the altatrack guidewire.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block a2: date of birth not provided.Block b6: no information available.Block c: not applicable for this device.Block d4: serial # not applicable.Blocks d6 & d7: not applicable for this device.Blocks e1 & g2: country is united kingdom.Blocks h3: the altatrack guidewire was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.Block h6: no device or use related root cause has been identified.Dissections during this kind of procedure are a known side effect and are covered by the device risk management.Blocks h7 & h9: 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: sinem acar ; veenpluis 6; best 5684 -PC ; NL 5684 PC ; 31643215596
• MDR Report Key: 17997772
• Report Number: 3003768277-2023-10506
• Device Sequence Number: 6681115
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)240718(10)8212847
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2023
• Report Date (Section F): 10/24/2023

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: 07/18/2024
• Device Model Number: ATG35120A
• Device Catalogue Number: ATG35120A
• Device Lot Number: 8212847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/10/2023
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: COOK: 22F FLEXOR INTRODUCER SHEATH; CORDIS: INFINITI 5F ANGIOGRAPHIC CATHETER; MEDTRONIC: TOURGUIDE 6.5F STEERABLE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 10/24/2023