MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX THIN-WALLED SHEATH, 8FR, 65CM; CATHETER, CONTINUOUS FLUSH

Model Number	30-103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is in transit to the manufacturer.Upon receipt of the device, a full evaluation will be completed.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 66-year-old female patient underwent arterial thrombectomy using inari devices.The patient's clot age was 30 days.During the thrombectomy, the artix thin-walled sheath (artix sheath) started to unravel and separate from the rest of the device during removal.The separated sheath had to be removed with a balloon.There were no reported injuries and the case was completed without further issue.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The suspect device was returned to the manufacturer and evaluated.The assigned root cause of the sheath separation is excessive force.Application of undue force while advancing or retracting the device against resistance, particularly in tortuous anatomy, can compromise catheter integrity.Manipulating in this way artix thin-walled sheath may have contributed to the observed separation in the returned device.Note that device labelling advises against manipulating the device through excessive force: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance, or advancement without the dilator fully inserted may result in damage to the device or vessel perforation." 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 stryker peripheral vascular medial affairs team determined that although there was no patient harm, if this malfunction were to recur it may cause or contribute to a death or serious injury.
Event or Problem Description
On (b)(6) 2025, a 66 year old female patient underwent arterial thrombectomy using inari devices.The patient's clot age was 30 days.During the thrombectomy, the artix thin-walled sheath (artix sheath) started to unravel and separate from the rest of the device during removal.The separated sheath had to be removed with a balloon.There were no reported injuries and the case was completed without further issue.

• Brand Name: ARTIX THIN-WALLED SHEATH, 8FR, 65CM
• 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: 24063615
• Report Number: 3020347218-2026-00001
• Device Sequence Number: 10266934
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)250919(10)25090081
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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 Model Number: 30-103
• Device Catalogue Number: 30-103
• Device Lot Number: 25090081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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 Age: 66 YR
• Patient Sex: Male