MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	ARISTOTLE 18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 07 mar 2023, scientia vascular was notified that on (b)(6) 2023, an aristotle 18 - 200cm support (a18-200-003) broke during an ischemic stroke case.The event was described as follows: "hypotube stuck and dislodged in the patient during ischemic stroke intervention.2nd pass with complete system wire stuck and could not be removed." the sample was not available for return to scientia vascular for evaluation.
Additional Manufacturer Narrative
Due to no lot number being provided for this complaint and no sample returned, no manufacturing evaluation or inspection of the unit was performed.Because the sample was not returned, it is impossible to determine what led the guidewire to break, but according to the information provided by the healthcare professional on this event, it appears the guidewire got stuck in the clot in the m3 vessel location, and after several attempts to remove the guidewire, the guidewire broke.During the meeting with the physician, he confirmed that post procedure scans did not show further complications related to the guidewire breakage and/or being lodged in the patient.Therefore, no patient injury was reported for this complaint.

• 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: raquel johnson ; 2460 south 3270 west; west valley city
• MDR Report Key: 16659736
• Report Number: 3009546466-2023-00002
• Device Sequence Number: 20625977
• Product Code: MOF
• UDI-Device Identifier: 00818075010110
• UDI-Public: 00818075010110
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183608
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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
• Operator of Device: Health Professional
• Device Model Number: ARISTOTLE 18
• Device Catalogue Number: A18-200-003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ZOOM 35; ZOOM 71; ZOOM 88
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown