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

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	12/23/2025
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 86 year old female patient underwent arterial thrombectomy using inari devices.The patient's clot age was 2 days old.During the thrombectomy, the artix funnel catheter (funnel catheter) unraveled at the hub upon removal.A hemostat was required to remove the portion of the catheter that remained in the patient's body.There were no reported injuries and the case was completed without further issue.
Additional Manufacturer Narrative
Manufacturer reference number is (b)(4).The suspect device was returned to the manufacturer and evaluated.The evaluation revealed that the root cause of the funnel catheter unravelling was a shaft length cutting issue.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.Although there was no patient harm with the funnel catheter unraveling, the information reasonably suggest that 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, an 86-year-old female patient underwent arterial thrombectomy using inari devices.The patient's clot age was 2 days old.During the thrombectomy, the artix funnel catheter (funnel catheter) unraveled at the hub upon removal.A hemostat was required to remove the portion of the catheter that remained in the patient's body.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, PRODUCT CODE: KRA
• 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: 24147468
• Report Number: 3020347218-2026-00004
• Device Sequence Number: 21166048
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)260915(10)25090081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/22/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG