MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX THIN-WALLED SHEATH, 8FR, 65CM; CATHETER, CONTINUOUS FLUSH

Model Number	30-103
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 20925, a male patient underwent arterial thrombectomy using inari devices.During the thrombectomy, the artix thin-walled sheath (artix sheath) and then the artix funnel catheter was inserted via the artix sheath.Two aspirations were performed with no clot removed.An attempt was made to exchange the guidewire; however, the attempt was unsuccessful.The artix funnel catheter was retracted back into the artix sheath.On imaging, the medical team noticed the radiopaque marker remained at the patient's femoral artery.The artix sheath and artix funnel catheter were removed from the patient without incident.The patient was then transferred to the operating room for an arterial cutdown to remove the marker band.
Additional Manufacturer Narrative
The inari devices were retained by the user facility and are unavailable for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted and no similar issues have been reported against this lot number.The device labeling includes the following warning: "avoid using excessive force to advance the artix sheath against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." the device labeling lists "additional surgical intervention" as a potential complication/adverse event.Manufacturer reference number: (b)(4).

• Brand Name: ARTIX THIN-WALLED SHEATH, 8FR, 65CM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 23846451
• Report Number: 3020347218-2025-00091
• Device Sequence Number: 18596261
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)251206(10)25060024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K241894
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 12/06/2025
• Device Model Number: 30-103
• Device Catalogue Number: 30-103
• Device Lot Number: 25060024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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
• Patient Sex: Male