MAUDE Adverse Event Report: MICROVENTION INC. SOFIA 5F-125CM STR; CATHETER INTRAVASCULAR DIAGNOSTIC

Model Number	DA5125ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient enrolled in the sofast clinical study was having a thrombectomy performed when a fragment of a clot in the m2 segment of the middle cerebral artery migrated distally after aspiration.There was no intervention and it was reported to have resolved without sequelae the same day.No diagnostic procedures were performed.The patient¿s nihss score improved to 14 the following day from their baseline score of 23 and improved to a score of 2 on october 9th.
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 device was not available for return to the manufacturer for evaluation.No diagnostic procedures were performed.The event as described could not be confirmed.The instructions for use identifies embolism as a potential complication associated with use of the device.
Additional Manufacturer Narrative
The device identification data that was previously provided in the initial mdr did not match the data in the gudid database.The previous udi number provided in the initial report was correct - no change required.
Event or Problem Description
It was reported that a patient enrolled in the sofast clinical study was having a thrombectomy performed when a fragment of a clot in the m2 segment of the middle cerebral artery migrated distally after aspiration.There was no intervention and it was reported to have resolved without sequelae the same day.No diagnostic procedures were performed.The patient's nihss score improved to 14 the following day from their baseline score of 23 and improved to a score of 2 on (b)(6).

• Brand Name: SOFIA 5F-125CM STR
• Common Device Name: CATHETER INTRAVASCULAR DIAGNOSTIC
• 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: 18315257
• Report Number: 2032493-2023-01113
• Device Sequence Number: 11579829
• Product Code: DQO
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)230719(17)260630(10)0000394435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2026
• Device Model Number: DA5125ST
• Device Lot Number: 0000394435
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: Other
• Patient Sex: Female