MAUDE Adverse Event Report: SCIENTIA VASCULAR ARISTOTLE 24 GUIDEWIRE; GUIDE, WIRE, CATHETER, NEUROVASCULATURE

Model Number	A24-200-002
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	07/19/2024
Type of Reportable Event	Death
Event or Problem Description
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.

• Brand Name: ARISTOTLE 24 GUIDEWIRE
• Common Device Name: GUIDE, WIRE, CATHETER, NEUROVASCULATURE
• Manufacturer (Section D): SCIENTIA VASCULAR
• MDR Report Key: 19876094
• Report Number: MW5157835
• Device Sequence Number: 7254393
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/26/2024

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: 09/30/2025
• Device Model Number: A24-200-002
• Device Lot Number: 502966
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Death
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 31 KG
• Patient Ethnicity: Hispanic