MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX THIN-WALLED SHEATH, 8FR, 90CM; 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	10/28/2025
Type of Reportable Event	Malfunction
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: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 59-year-old female underwent arterial thrombectomy using inari devices.The patient's clot age was estimated at 14 days.During the procedure, clot was removed on the right after seven passes with the the artix mechanical thrombectomy device (mt6) and a stent was placed in the right iliac artery.While completing fluoroscopy, some clot was embolized as a result of ballooning.One more pass using the mt6 removed the embolized clot.Imaging confirmed normal findings.All devices were removed through the artix thin-walled sheath (artix sheath), however upon removal of the dilator, the dilator would not retract.The physician pulled the artix sheath and the sheath came apart in a section.The physician moved closer to the access and pulled again, which resulted in another tear in the sheath.The physician used hemostats and increased the dilation of the site, and everything was fully removed.
Event or Problem Description
On (b)(6) 2025, a 59-year-old female underwent arterial thrombectomy using inari devices.The patient's clot age was estimated at 14 days.During the procedure, clot was removed on the right after seven passes with the artix mechanical thrombectomy device (mt6) and a stent was placed in the right iliac artery.While completing fluoroscopy, some clot was embolized as a result of ballooning.One more pass using the mt6 removed the embolized clot.Imaging confirmed normal findings.All devices were removed through the artix thin-walled sheath (artix sheath), and the artix sheath dilator was reinserted while removing the artix sheath.Upon removing the artix sheath, resistance was felt.The physician pulled the artix sheath and the sheath came apart in a section.The physician moved closer to the access and pulled again, which resulted in another tear in the sheath.The physician used hemostats and increased the dilation of the site, and everything was fully removed.
Additional Manufacturer Narrative
Additional manufacturer narrative: the artix thin-walled sheath (artix sheath) was returned to the manufacturer and investigated.Visual inspection confirmed the artix sheath had five areas where the sheath shaft had separated and the coil was exposed.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 artix sheath most likely separated due to excessive force used to advance/retract the device against resistance.The device labeling includes the following warning: "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." correction to initial report (3020347218-2025-00085), section b5: initial report stated "all devices were removed through the artix thin-walled sheath (artix sheath), however upon removal of the dilator, the dilator would not retract." b5 should read "all devices were removed through the artix thin-walled sheath (artix sheath), and the artix sheath dilator was reinserted while removing the artix sheath.Upon removing the artix sheath, resistance was felt." manufacturer reference number: (b)(4).

• Brand Name: ARTIX THIN-WALLED SHEATH, 8FR, 90CM
• 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: 23648552
• Report Number: 3020347218-2025-00085
• Device Sequence Number: 4824837
• Product Code: KRA
• UDI-Device Identifier: 00810123710577
• UDI-Public: (01)00810123710577(17)260513(10)25050074R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 05/13/2026
• Device Model Number: 30-104
• Device Catalogue Number: 30-104
• Device Lot Number: 25050074R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 79 KG