MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW PLUS 6F; ASPIRATION CATHETER

Model Number	DA6125ST-ASP-US-OD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The study device was not retained and returned to the manufacturer for evaluation.The alleged possible association between the catheter and the occlusion could not be confirmed.
Event or Problem Description
It was reported through the restore clinical study that 100 days post thrombectomy procedure, a cta demonstrated progressive steno-occlusive process of rm1 segment of the mca.The patient was kept on dapt and sent for an angiogram three days later, which demonstrated complete occlusion of the right mca.The distal branches were filled via aca collaterals and there was also some collateralization from lenticulostriate branches.It was planned for the patient to continue asa and atorvastatin indefinitely.The patient was still asymptomatic 109 days from the surgery during a follow up visit.It was reported that the patient's condition was definitely related to the study disease, possibly related to the thrombectomy procedure, and possibly related to the aspiration catheter.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: ASPIRATION CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19081115
• Report Number: 2032493-2024-00284
• Device Sequence Number: 20490868
• Product Code: DQY
• UDI-Device Identifier: 00842429108475
• UDI-Public: (01)00842429108475(11)230508(17)260430(10)0000359506
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K214024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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: 04/30/2026
• Device Model Number: DA6125ST-ASP-US-OD
• Device Lot Number: 0000359506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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; Other
• Patient Sex: Female