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

Model Number	30-103
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a female patient underwent arterial thrombectomy using inari devices.The patient had pre-existing stents in the left common iliac and left superficial femoral arteries and preexisting bypass grafts in the left superficial femoral and left peroneal arteries.The patient's clot age was estimated at eight days.During the thrombectomy, resistance was felt when the artix thin-walled sheath (artix sheath) was advanced to the patient's left side arteries.It was believed the artix sheath was caught on a strut of the patient's preexisting stent.When the artix sheath was retracted, the marker band had separated from the device.The physician inflated a balloon inside of the radiopaque marker band and removed the band and balloon from the patient's body without issue.A new device was used, and the case was completed without any additional issues.
Additional Manufacturer Narrative
The inari devices were retained by the user facility and are not available for evaluation.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 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." the device labeling includes the following precautions: "use caution when manipulating or advancing the artix sheath through a stent or graft." "be aware of the position of the artix sheath in relation to the blood vessel when inserting, manipulating, or withdrawing a device through the artix sheath." "ultrasound guidance should be used to ensure desired vessel target area is accessed during the artix sheath placement." manufacturer reference:(b)(4).

• 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: 22071142
• Report Number: 3020347218-2025-00033
• Device Sequence Number: 8702482
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)250928(10)25030150
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 09/28/2025
• Device Model Number: 30-103
• Device Lot Number: 25030159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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 DEVICE
• Patient Sex: Female