MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	00919
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a neurovascular procedure an aristotle 18 guidewire was used to help clear a clot.Because of how much clot there was the physician could not access the sagittal sinus.The case was reported to be a 4-5 hour long case and they noticed the aristotle 18 guidewire was broken when they removed it from the patient.They did not pull another wire as the case was as complete as they could get it.It was noted the patient was in rough condition, but this was not due to the guidewire break.There was no injury to the patient as a result of the malfunction.
Additional Manufacturer Narrative
From the review of the manufacturing lot history record, there is no indication that the break occurred due to a manufacturing defect, and it confirms the lot met the releasing criteria.

• 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: 24319442
• Report Number: 3009546466-2026-00020
• Device Sequence Number: 10154038
• Product Code: MOF
• UDI-Device Identifier: 00818075010110
• UDI-Public: 00818075010110
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 05/31/2025
• Device Model Number: 00919
• Device Catalogue Number: A18-200-003
• Device Lot Number: 028144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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: MEDTRONIC APRO 70 CATHETER; MEDTRONIC PHENOM 21 CATHETER; PENUMBRA BENCHMARK BMX 96 ACCESS SYSTEM
• Patient Sex: Unknown