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

Model Number	30-103
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Visual inspection at 20x and 40x magnification revealed the artix thin-walled sheath (artix sheath) endured damage consistent with excessive compression and tensile forces adjacent to the break location.The undamaged section of the sheath did not have evidence of liner delamination.The artix sheath was damaged likely due to excessive force used to track the sheath through the patient's preexisting stent.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 device labeling includes the following warning statements: "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." the device labeling includes the following precaution: "use caution when manipulating or advancing the artix sheath through a stent or graft." manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025, a male patient underwent right lower extremity arterial thrombectomy using inari devices.The patient had a history of peripheral artery disease and had a preexisting stent in the right superficial femoral artery and a bypass graft in the right common femoral and popliteal arteries.The patient's clot age was estimated at two days.The target treatment area was in the right popliteal and tibial arteries.At the end of the thrombectomy, the artix thin-walled sheath unraveled upon exiting the patient's left common femoral artery.A stiff angled glidewire was placed through the portion of the sheath that remained in the patient's body and a hemostat was used to remove the remaining portion of the sheath completely.The case was concluded without further issues and the patient had full flow resorted post-thrombectomy.

• Brand Name: ARTIX THIN-WALLED SHEATH
• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 22073671
• Report Number: 3020347218-2025-00035
• Device Sequence Number: 8703091
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)250826(10)25020131
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2025
• Device Model Number: 30-103
• Device Lot Number: 25020131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTIX MECHANICAL THROMBECTOMY CATHETER
• Patient Sex: Male
• Patient Weight: 91 KG