MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX MT THROMBECTOMY DEVICE, 4-8MM, 130CM; CATHETER, CONTINUOUS FLUSH

Model Number	32-103
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a female patient underwent lower left extremity thrombectomy using stryker devices.The procedure was successful.After completion of the procedure, fluoroscopy showed presence of a radiopaque marker band from the atrix mt8.Attempts were unsuccessful at removing the marker band intravascularly and it was removed surgically.
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).

• Brand Name: ARTIX MT THROMBECTOMY DEVICE, 4-8MM, 130CM
• 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: 25279838
• Report Number: 3020347218-2026-00042
• Device Sequence Number: 21353713
• Product Code: KRA
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)260925(10)25090143
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 05/26/2026

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 Expiration Date: 09/25/2026
• Device Model Number: 32-103
• Device Catalogue Number: 32-103
• Device Lot Number: 25090143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female