MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE 24; GUIDEWIRE

Model Number	ARISTOTLE 24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	07/19/2024
Type of Reportable Event	Death
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.
Event or Problem Description
On 22 jul 2024, scientia vascular was notified that an a24-200-002 guidewire fractured during a neurovascular procedure, attempts to gather more information between the scientia vascular sales representative and the hospital occur, and no additional information was provided.On 26 jul 2024, details of the event were provided to scientia vascular.The event was described as follows: "during mechanical thrombectomy for acute stroke, the distal tip of the reperfusion catheter tip separated.After successful recanalization, it appeared that the catheter tip was retained in the thrombosis and ultimately migrated; resulted in m1 occlusion.An aristotle 24 guidewire was used to try to obtain the broken catheter tip, the guidewire also fractured and contributed to the occlusion.Occlusion could not be cleared.Many attempts to retrieve catheter tip and guidewire with a variety of strategies were unsuccessful." the complaint guidewire was not returned to scientia vascular for evaluation, despite sales representative attempts to collect the guidewire.

• Brand Name: ARISTOTLE 24
• 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: 20005961
• Report Number: 3009546466-2024-00011
• Device Sequence Number: 17251122
• Product Code: MOF
• UDI-Device Identifier: 00818075010134
• UDI-Public: (01)00818075010134(17)250930(10)502966
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: ARISTOTLE 24
• Device Catalogue Number: A24-200-002
• Device Lot Number: 502966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REPERFUSION CATHETER ZOOM 55
• Outcome Attributed to Adverse Event: Life Threatening; Death; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 31 KG
• Patient Ethnicity: Hispanic