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

Model Number	30-103
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a 67-year-old male patient underwent a thrombectomy procedure using the artrix system of devices.During removal of the device the sheath failed at the distal portion.Additional surgery was performed to retrieve sheath tip and sheath.
Additional Manufacturer Narrative
Manufacturer reference number (b)(4).The suspect device has been received by the manufacturer, and a full evaluation has been completed.The assigned root cause of the tip separation a fatigue failure due to excessive force and tortuous patient anatomy.As significant scratching damage was observed along the dilator and sheath shaft surfaces, it is likely that the sheath was inserted through tortuous anatomy with hardened organic material like chronic calcified clot.This tortuous anatomy likely created resistance when advancing or retracting the device leading to the observed fatigue failure.Device labelling warns against advancing and retracting the device in the presence of excessive force, as it can cause device damage.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 device likely contributed to the patient's need for a venous cutdown.The device labelling lists additional surgical intervention as a possible adverse event associated with use.

• 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: 25337903
• Report Number: 3020347218-2026-00044
• Device Sequence Number: 10128614
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)280123(10)26010116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/29/2026

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: 26010116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 62 KG