MAUDE Adverse Event Report: Inari Medical, Inc. Artix Thin-Walled Sheath, 8Fr, 65cm; Catheter, Continuous Flush

Model Number	30-103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a thrombectomy with the artix system of devices on (b)(6) 2026.Mid procedure, the artix sheath separated at the junction of the hemostasis valve and became stuck in the body.The funnel catheter remained inside the sheath.This was noticed under fluoro imaging and confirmed by seeing the funnel catheter outside of body.Removing the device required bilateral cutdowns.The patient was then treated with a different intervention.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The suspect device was not returned to the manufacturer and could not be evaluated.As such, no root cause for the product malfunction could be found.A complaint history review was conducted and no similar issues have been reported against this lot number.We are awaiting receipt of one subassembly lot record to finish the product history review.As it stands, no discrepancies could be found.Once that lot record has been received, a subsequent report with the full product history review will be sent.The stryker peripheral vascular medial affairs team determined that the artix device may have caused or contributed to the patient's need for a venous cutdown.The device labeling lists vascular trauma as a possible adverse event/complication.

• 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 ; +1(949)413-2147
• MDR Report Key: 50087073
• Report Number: 3020347218-2026-00056
• Device Sequence Number: 21353168
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)280204(10)26020020
• 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): 07/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 30-103
• Device Catalogue Number: 30-103
• Device Lot Number: 26020020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Weight: 171 LB