MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; ARISTOTLE 14 GUIDEWIRE

Model Number	ARISTOTLE 14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, scientia vascular personnel were notified that an a14-200-001 (lot #:023431) guidewire broke during the procedure at (b)(6) hospital.A follow-up conversation with the sales representative indicated that the physician used a snare to retrieve the broken distal portion of the guidewire.
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 was built to specification.There is no way to confirm every step taken that could have led the guidewire to break.However, it appears that the failure of the returned unit may have been due to bending and fatiguing during the procedure, as it was also determined during the investigation of the complaint on file.When and how the guidewire bending occurred cannot be confirmed due to the limited information provided.

• Brand Name: ARISTOTLE
• Common Device Name: ARISTOTLE 14 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: 18636098
• Report Number: 3009546466-2024-00001
• Device Sequence Number: 18115097
• Product Code: DQX
• UDI-Device Identifier: 00818075010004
• UDI-Public: 00818075010004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/02/2024

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: 08/31/2024
• Device Model Number: ARISTOTLE 14
• Device Catalogue Number: A14-200-001
• Device Lot Number: 023431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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