MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	ARISTOTLE 18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 30-may-2024, a scientia vascular was notified of a complaint about an aristotle 18 guidewire tip breaking and being left in the patient.The complaint unit was not available for return to scientia vascular.
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.The complaint device was not returned to the manufacturer for inspection.For these reasons, no results were obtained.

• 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, UT 84119
• MDR Report Key: 19610645
• Report Number: 3009546466-2024-00007
• Device Sequence Number: 6237006
• Product Code: MOF
• UDI-Device Identifier: 00818075010097
• UDI-Public: 00818075010097
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K231954
• 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): 06/07/2024

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 Expiration Date: 10/31/2024
• Device Model Number: ARISTOTLE 18
• Device Catalogue Number: A18-200-001
• Device Lot Number: 024547
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2023
• 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: SOLITAIRE X
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown