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

Model Number	30-103
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to supplement an initial mdr mailed on 3/13/2026 due to a temporary system outage affecting the manufacturer's complaint handling system.Although this report is being submitted as an initial report due to system limitations, it is intended as a follow-up report to the previously submitted paper mdr (b)(4).The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturers reference number (b)(4).
Event or Problem Description
On (b)(6) 2026 a patient underwent arterial thrombectomy using stryker peripheral vascular devices.At the end of the thrombectomy, the artix thin-walled sheath encountered resistance when attempting to remove the sheath.As the physician pulled the sheath, the sheath unraveled.An arterial cutdown was performed to remove the sheath.
Event or Problem Description
On (b)(6) 2026, a patient underwent arterial thrombectomy using stryker peripheral vascular devices.At the end of the thrombectomy, the artix thin-walled sheath encountered resistance when attempting to remove the sheath.As the physician pulled the sheath, the sheath unraveled.An arterial cutdown was performed to remove the sheath.
Additional Manufacturer Narrative
The device malfunctioned, which resulted in the need for medical intervention in the form of a venous cutdown.The suspect device was returned and evaluated.The root cause of the catheter separation was most likely due to procedural factors such as excessive manipulation during the procedure.Excessive force used to advance or retract the device against resistance can cause damage to the catheter.Per device labelling: "do not advance without dilator fully inserted.Avoid using excessive force to advance or retract against resistance." 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.

• 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: 24651241
• Report Number: 3020347218-2026-00024
• Device Sequence Number: 15913300
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)261117(10)25110082
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/24/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Male