MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	01322
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	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.
Event or Problem Description
During a neurovascular procedure a aristotle colossus guidewire (acl-200-002) was pulled out ot the hoop and hydrated in a bowl ol heparinized saline during procedure.The phsyicians got access to both femoral artery and vein for venous sinus pressure measurements.They shaped the wire to desired effect and tracked the wire and both th6 4f glide catheter, then the 5f envoy to desired positions.The 4f angled glide catheter was placed just past the ica orgin.The 5f envoy was tracked through the venous system and ended up being placed at the torqula.When tracking through the venous sinuses the operator needed a bit of a dillerent shape, he pulled the wire, reshaped it and ended up being able to advance the wire through the sagittal sinus and the catheter to its resting postition in the transverse sinus iust proximal to the torcula.They took the wire out and then placed a marksman catheter and an a24-200-002 to finish the procedure and taking pressures.After looking at the acl at the end of the case, the operator noticed it looked like the wire got a bit stretched in the shaping section of the wire.He asked if we could take it back and look at it just to ensure nothing is wrong.They did not switch wires due to a failure of the wire.There was no injury to 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: 24309564
• Report Number: 3009546466-2026-00023
• Device Sequence Number: 20143662
• Product Code: MOF
• UDI-Device Identifier: 00818075010691
• UDI-Public: 00818075010691
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 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: 01/31/2024
• Device Model Number: 01322
• Device Catalogue Number: ACL-200-002
• Device Lot Number: 020988
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J & J HEALTHCARE SYSTEMS ENVOY 5F GUIDING CATHETER; TERUMO GLIDECATH 4F CATHETER
• Patient Sex: Unknown