MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE; GUIDEWIRE

Model Number	ARISTOTLE 18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9th of jan, 2023 scientia vascular sales representative was notified that an a18-200-001 guidewire broke during a stroke procedure and the broken portion of the guidewire was retrieved.Further conversation with the sales representative indicated that a snare was used to retrieve the broken portion of the guidewire, and that the procedure was sucessfully completed using a different guidewire.There was no patient injury.The complaint unit was collected on 17 jan 2023 and returned to scientia vascular on 19 jan 2023.
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.Due to the limited information provided, there is no way to confirm every step taken that could have led the guidewire to break, but from the information collected in this investigation, the guidewire appears to have broken due to the guidewire bending, but the root cause for the break could not be determined.

• 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: 16330495
• Report Number: 3009546466-2023-00001
• Device Sequence Number: 17853887
• Product Code: MOF
• UDI-Device Identifier: 00818075010097
• UDI-Public: 00818075010097
• 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): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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
• Device Expiration Date: 07/31/2025
• Device Model Number: ARISTOTLE 18
• Device Catalogue Number: A18-200-001
• Device Lot Number: 502865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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
• Patient Sex: Unknown