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

Model Number	30-103
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is in transit to the manufacturer.Upon receipt of the device a full evaluation will be completed, and a follow-up report will be submitted.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2026, a patient underwent arterial thrombectomy using the inari artix system.After completion of the thrombectomy portion of the procedure, the artix mechanical thrombectomy device (mt8) was successfully removed and a supera stent was inserted into the patient's right leg.The stent elongated upon deployment, which resulted in the stent being extended into the artix funnel catheter.The artix funnel catheter and artix thin-walled sheath (artix sheath) would not release the stent.The supera stent catheter then broke upon retraction, leaving the distal catheter trapped on the guidewire within the funnel catheter and artix sheath.The physician advanced the artix sheath to remove the funnel catheter and resistance was noted.The physician then inserted the dilator and the distal tip of the stent delivery system advanced distally and became visible.The physician attempted to remove the supera stent delivery system; however, was unable to remove the system without force, therefore the decision was made to transfer the patient to surgery to perform a cutdown to remove the stent system, the funnel catheter, and artix sheath.
Additional Manufacturer Narrative
The manufacturer's reference number: (b)(4).The suspect device was returned to the manufacturer and evaluated.The assigned root cause of the sheath interaction issue is excessive force when advancing/retracting the device against resistance.Excessive force when in use cause device damage.Per device labelling: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance, or advancement without the dilator fully inserted may result in damage to the device or vessel perforation,".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 stryker peripheral vascular medial affairs team determined the artix sheath may have caused or contributed to the stent interaction, thus resulting in the venous cutdown.The device labeling includes additional surgical intervention, such as the venous cutdown, as a possible adverse event/complication.
Event or Problem Description
On (b)(6) 2026, a patient underwent arterial thrombectomy using the inari artix system.After completion of the thrombectomy portion of the procedure, the artix mechanical thrombectomy device (mt8) was successfully removed and a supera stent was inserted into the patient's right leg.The stent elongated upon deployment, which resulted in the stent being extended into the artix funnel catheter.The artix funnel catheter and artix thin-walled sheath (artix sheath) would not release the stent.The supera stent catheter then broke upon retraction, leaving the distal catheter trapped on the guidewire within the funnel catheter and artix sheath.The physician advanced the artix sheath to remove the funnel catheter and resistance was noted.The physician then inserted the dilator and the distal tip of the stent delivery system advanced distally and became visible.The physician attempted to remove the supera stent delivery system; however, was unable to remove the system without force, therefore the decision was made to transfer the patient to surgery to perform a cutdown to remove the stent system, the funnel catheter, and artix sheath.

• 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: 24526865
• Report Number: 3020347218-2026-00020
• Device Sequence Number: 12871597
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: 00810123710560
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 05/14/2026

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 Model Number: 30-103
• Device Catalogue Number: 30-103
• Device Lot Number: 25110082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown