MAUDE Adverse Event Report: Scientia Vascular Aristotle Colossus; Guidewire

Model Number	01322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the event occurred during an aspiration thrombectomy and an aristotle colossus guidewire broke during the procedure.The physician noted the wire was initially difficult to pull back into the zoom 7x catheter with moderate resistance like other times when a wire felt a little sticky, but it came back.As it was removed from the hub, there was a longer, very thin strand that looked unwound attached to the tip.The physician assumed that must have broken off on the back table when the fellow or tech was handling it, but they were not paying attention to that and were looking at the fluoro screen completing the procedure.This was a one pass, successful aspiration thrombectomy, and the wire was only inserted once, and the wire was only shaped once.The physician did not see any wire left in the patient at the end of the procedure and nothing needed to be retrieved.There was no adverse impact on the patient from the malfunctioned guidewire.

• Brand Name: Aristotle Colossus
• Common Device Name: Guidewire
• Manufacturer (Section D): Scientia Vascular; 2460 south 3270 west; west valley city UT 84119
• Manufacturer (Section G): Scientia Vascular; 2360 south 3270 west; west valley city UT 84119
• Manufacturer Contact: joshua verlac ; 2460 south 3270 west; west valley city, UT 84119
• MDR Report Key: 50897777
• Report Number: 3009546466-2026-00055
• Device Sequence Number: 5904119
• Product Code: MOF
• UDI-Device Identifier: 00818075010691
• UDI-Public: 00818075010691
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K222437
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01322
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 052424
• 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: 01/05/2026
• 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: Imperative Care Zoom 7x Aspiration Catheter.
• Patient Sex: Male