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

Model Number	30-104
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.Visual inspection at 0x, 20x, and 40x magnification of the artix thin-walled sheath (artix sheath) revealed damage consistent with heavy disease and tortuous anatomy, including scraping of the outer jacket and anatomy induced deformations in the catheter.Further inspection of undamaged section of sheath did not demonstrate delamination of the liner.The sheath damage was likely caused by tortuous anatomy and underlying disease that created worst case conditions for sheath usage.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: "adequate vessel access is required to introduce the artix sheath into the vasculature.Careful evaluation of vessel size, anatomy, tortuosity, and disease state (including plaque, calcifications, and thrombus) is required to ensure successful sheath introduction and subsequent withdrawal.If vessel is not adequate for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result." "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." manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 69-year-old male patient underwent arterial thrombectomy using inari devices.The patient's clot age was estimated at 20 days.At the end of the thrombectomy, while removing the artix thin-walled sheath, without the dilator, resistance was felt, which resulted in the device becoming stuck.An attempt was made to insert the dilator, however the dilator would not advance.Fluoroscopy showed the marker band had separated and was caught around the aortic bifurcation.An arterial cutdown was performed to retrieve the marker band, which was successful.
Additional Manufacturer Narrative
Correction to section d4 in intial report 3020347218-2025-00059.Section d4 model # should read "30-104".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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 23022265
• Report Number: 3020347218-2025-00059
• Device Sequence Number: 21267746
• Product Code: KRA
• UDI-Device Identifier: 00810123710577
• UDI-Public: (01)00810123710577(17)260520(10)25050117R
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 05/20/2026
• Device Model Number: 30-104
• Device Lot Number: 25050117R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTIX MECHANICAL THROMBECTOMY CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 82 KG