MAUDE Adverse Event Report: Scientia Vascular Aristotle; Guidewire

Model Number	00775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an mma embolization procedure an aristotle 14 guidewire broke inside of a patient approximately 5-7cm from the distal tip.The guidewire broke outside of the catheter in the patient's vasculature and required aspiration to remove the broken portion of the guidewire from the patient.The physician noted there was some tortuosity, but when they switched to a synchro wire there were no issues.It was reported that the event did not have any adverse impact on the patient.

• 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: 50897779
• Report Number: 3009546466-2026-00057
• Device Sequence Number: 17618272
• Product Code: DQX
• UDI-Device Identifier: 00818075010011
• UDI-Public: 00818075010011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173235
• 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): 09/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00775
• Device Catalogue Number: A14-200-002
• Device Lot Number: 051654
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2026
• 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: J&J Cereglide Catheter.; J&J MedTech Prowler EX Microcatheter.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown