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 Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Report source: 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.
Event or Problem Description
It was reported that an altatrack guidewire was used in a peripheral evar procedure.During navigation, a dissection occurred and perforated the distal left renal artery.The dissection resolved itself; therefore, no stent placement was required.The patient was discharged as normal.This adverse event is being submitted because a dissection occurred.There was no alleged malfunction with the altatrack guidewire.
Additional Manufacturer Narrative
Block b2: outcomes attributed to adverse event is updated from "other" to "required intervention".Block b5: updated based on additional information received that a stent was placed to cover the dissection.Block f10: health effect impact code is updated from 4613 (minor injury/ illness / impairment) to 4614 (serious injury/ illness/ impairment) and 4641 (unexpected medical intervention).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.
Event or Problem Description
It was reported that an altatrack guidewire was used in a peripheral evar procedure.During navigation, a dissection occurred and perforated the distal left renal artery, requiring stent placement.The patient was discharged as normal.This adverse event is being submitted because a dissection occurred and required stent placement.There was no alleged malfunction with the altatrack guidewire.
Additional Manufacturer Narrative
Block b5: added perforation to the event description.Block f10: hecc code fda# 2135 (perforation of vessels) is included.In the initial mdr, hecc code fda# 3160 (vascular dissection) was listed and remains appropriate.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.
Event or Problem Description
This adverse event is being submitted because a dissection and perforation occurred; requiring stent placement.There was no alleged malfunction with the altatrack guidewire.

• 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: 16576915
• Report Number: 3003768277-2023-10502
• Device Sequence Number: 5896020
• Product Code: DQX
• UDI-Device Identifier: 00884838070974
• UDI-Public: (01)00884838070974(17)231109(10)7276921
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 03/19/2024
• Report Date (Section F): 03/19/2024

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: 432207013481
• 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: 02/19/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/18/2023; 02/19/2024
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/24/2023; 03/19/2024
• 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: 7F TOURGUIDE INTRODUCER SHEATH.; GORE: 12F DRYSEAL FLEX INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 03/19/2024