MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE 14; GUIDEWIRE

Model Number	ARISTOTLE 14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing lot history record indicated that the lot met the release criteria.Several attempts were made to gather more information for this case, on (b)(6) 2023, (b)(6) 2023, and (b)(6) 2023, but no additional information was provided.Due to the limited information provided during the complaint submission, and the returned complaint unit inspection not identifying any damage to the guidewire that would indicate that the guidewire was the cause of the vessel dissection, this complaint investigation will remain on file, but the root cause for the vessel dissection could not be determined.The doctor was able to tend to the event by coiling the vessel, preventing permanent injury to the patient.Scientia vascular was also notified that the patient was doing well.
Event or Problem Description
On (b)(6) 2023, scientia vascular personnel was notified that a doctor was using an aristotle 14 guidewire (a14-200-002 ln:021236) during a neurovascular procedure when a vessel was dissected, and needed intervention.The event was described as follows: "mma case the tip of the wire seemed to have a sharp edge to it and would not shape normally.The product resulted in a vessel dissection.The physician was fortunately able to coil off the vessel, it was the extracranial / skull base region of the mma.The patient is doing well." the guidewire was returned to scientia vascular for evaluation on (b)(6) 2023.No information was provided regarding the other product used during the case.

• Brand Name: ARISTOTLE 14
• 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: raquel johnson ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 17421534
• Report Number: 3009546466-2023-00005
• Device Sequence Number: 8901804
• Product Code: MOF
• UDI-Device Identifier: 00818075010011
• UDI-Public: 00818075010011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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?: Yes
• Device Expiration Date: 02/28/2024
• Device Model Number: ARISTOTLE 14
• Device Catalogue Number: A14-200-002
• Device Lot Number: 021236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2023
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown