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

Model Number	884838070974
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a peripheral therapeutic procedure, a.035" altatrack guidewire was used in a fevar procedure.During navigation in the right renal artery, resistance was encountered and unable to advance; therefore, the altatrack guidewire was swapped with a non-philips guidewire.The non-philips guidewire was advanced further into the right renal artery, and using angio, a dissection was noted.The physician believes the dissection was caused by the altatrack guidewire.The physician then continued to cannulate the left renal artery with a non-philips catheter over an altatrack guidewire, but resistance was noted.Thus, the altatrack guidewire was swapped with a non-philips guidewire.Angio was performed in the left renal artery when a dissection was noticed.The physician was unsure which guidewire caused the dissection.Both dissections in the left and the right renal arteries were treated successfully with various types of stents.The patient was fine and discharged 3 days post procedure.This adverse event is being submitted because the altatrack guidewire may have caused a dissection, and required stent placement.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Study name - fors learn.The altatrack guidewire was discarded and not returned to the manufacturer for evaluation, thus no returned product investigation was performed.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: 16686824
• Report Number: 3003768277-2023-10503
• Device Sequence Number: 6080486
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)231109(10)7276921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Importer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2023
• Report Date (Section F): 04/05/2023

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: 11/09/2023
• Device Model Number: 884838070974
• Device Catalogue Number: 432207013483
• Device Lot Number: 7276921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/15/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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: 8.5F TOURGUIDE INTRODUCER SHEATH; COOK: 5F VAN SCHIE GUIDE CATHETER; GORE: 16F DRYSEAL FLEX INTRODUCER SHEATH; MERIT: SIZE UNK BERN GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 04/05/2023