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

Model Number	30-104
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inari devices were discarded 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 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 47-year-old male underwent arterial thrombectomy using inari devices.The patient's clot age was estimated at 60 days.After deploying the artix funnel catheter, the radiopaque marker on the distal end of the artix thin-walled sheath (artix sheath) separated from the sheath.The marker remained on the guidewire.The physician used a biopsy catheter to successfully retrieve and remove the marker band from the patient's vasculature.Upon inspection of the marker band, there was a clean break, and no tearing or unraveling was observed.The case continued, and nearly all the clot was removed from the patient's preexisting stent.The patient had full flow restored after the thrombectomy.
Additional Manufacturer Narrative
Correction to section d4 in intial report 3020347218-2025-00045.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: 22460393
• Report Number: 3020347218-2025-00045
• Device Sequence Number: 8550912
• Product Code: KRA
• UDI-Device Identifier: 00810123710577
• UDI-Public: (01)00810123710577(17)251009(10)25040047
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2025
• Device Model Number: 30-104
• Device Lot Number: 25040047
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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 MT MECHANICAL THROMBECTOMY DEVICE.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 116 KG