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	Vascular Dissection (3160)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a 73-year-old male patient underwent arterial thrombectomy using inari devices.The patient had a history of multiple procedures at the groin site, which resulted in notable scar tissue at the access site.During the thrombectomy, the artix thin-walled sheath (artix sheath) became stuck in the patient's vasculature and when the physician attempted to remove the artix sheath, the device separated.The physician was able to remove the artix sheath by performing an arterial cutdown in the catheterization laboratory.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer reference number pi (b)(4).
Event or Problem Description
On (b)(6) 2025, a 73-year-old male patient underwent arterial thrombectomy using inari devices.The patient had a history of multiple procedures at the groin site, which resulted in notable scar tissue at the access site.During the thrombectomy, the artix thin-walled sheath (artix sheath) became stuck in the patient's vasculature and when the physician attempted to remove the artix sheath, the device separated.The physician was able to remove the artix sheath by performing an arterial cutdown in the catheterization laboratory.
Additional Manufacturer Narrative
The artix thin-walled sheath (artix sheath) was returned to the manufacturer and evaluated.The artix sheath was returned with the dilator inserted.The sheath shaft exhibited areas of exposed coil and damage reflective of stretching the to the shaft wall approximately halfway from the distal end of the sheath.The section of the sheath shaft proximal to the coil displayed a consistent crumpling pattern.An attempt was made to remove the dilator after the device was decontaminated; however, the attempt was unsuccessful as the sheath shaft appeared to be stretched and tightened over the dilator shaft.The sheath was then further inspected under a digital microscope, and no material defects or manufacturing assembly errors were observed.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 reported complaint of a sheath separation was not confirmed.However, damage to the sheath shaft was observed.The most probable root cause for the artix sheath shaft damage is excessive force advancing and retracting against resistance created by a tortuous pathway.The device labeling includes the following warnings: ¿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.¿ ¿never advance or torque the artix sheath against resistance without careful assessment of cause of resistance using fluoroscopy.¿ 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: 23783998
• Report Number: 3020347218-2025-00089
• Device Sequence Number: 17416422
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)260820(10)25080102
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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 Expiration Date: 08/20/2026
• Device Model Number: 30-103
• Device Catalogue Number: 30-103
• Device Lot Number: 25080102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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 Age: 73 YR
• Patient Sex: Male