MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	00897
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a aneurysm case using an aristotle 24 (a24-200-002) guidewire by radial access the physician noted the catheter kinked and the guidewire got caught and stretched.The physician mentioned the guidewire performing well going into the ica and the guidewire tip was responding as expected up until the guidewire broke.The physician also mentioned they decided to perform the procedure through the arm / shoulder and that it was a tortuous pathway with a sharp turn and was hard to navigate.The physician lost tip control when they witnessed the catheter kinking and the guidewire stretching.The physician pulled everything out and decided to switch access to the groin instead using a new aristotle 24.The procedure was completed without issue.
Additional Manufacturer Narrative
The manufacturing evaluation indicates that lot number: 020197 met the release criteria, no abnormalities were found on the guidewire that would indicate the corewire had slipped out of the dome, or that the break could have been caused by a material or manufacturing defect.As discussed with the doctor, they mentioned that they witnessed a kink on the microcatheter, there was a sharp turn before the guidewire broke and stretched.There is no way to confirm what caused the guidewire to break, due to the conversation with the doctor regarding this complaint, and the images collected during the investigation, they do not indicate that the guidewire break and stretching was due to a design or manufacturing defect.Because the doctor was able to complete the procedure and no patient injury occurred, therefore no update to the risk documentation is necessary.

• Brand Name: ARISTOTLE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): SCIENTIA VASCULAR; 2460 south 3270 west; west valley city UT 84119
• Manufacturer Contact: joshua verlac ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 23699343
• Report Number: 3009546466-2025-00018
• Device Sequence Number: 21102973
• Product Code: MOF
• UDI-Device Identifier: 00818075010134
• UDI-Public: 00818075010134
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K231954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 00897
• Device Catalogue Number: A24-200-002
• Device Lot Number: 020197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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: MEDTRONIC PHENOM 27 CATHETER.; MEDTRONIC RIST GUIDE CATHETER.
• Patient Sex: Unknown