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

Model Number	32-103
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a 48 year old female underwent lower right extremity bypass thrombectomy using stryker devices.Initial passes with the artix mt8 were successful.Following balloon angioplasty, the catheter became entrapped during the fifth pass.Bailout and mitigation techniques were attempted without success.A decision was made to remove the entire system.During withdrawal, the catheter became stuck at the puncture site.The physician elected to convert the puncture site to an open cutdown for device removal.Upon performing the cutdown and extracting the device, it was noted the catheter contained large, chronic thrombus.After device removal, the physician found reduced flow to the right lower extremity due to vessel injury at the access site.The physician then performed an extended cutdown, which revealed a dissection at that location.The dissection was repaired and the site was surgically closed.
Additional Manufacturer Narrative
The suspect device will not be returned to the manufacturer.As such, it could not be investigated and a root cause for the issue could be be assigned.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 case was reviewed with the stryker pv medical affairs team who deemed the patient required a cutdown due to user error.(not indicated for the removal of fibrous, adherent, or calcified material (e.G., atherosclerotic plaque)).Per device labelling: "warning: ensure that the self-expanding element is withdrawn into the introducer sheath and/or catheter prior to removal from patient to avoid vascular damage.Potential complications: vessel dissection/perforation.Contraindications: not indicated for the removal of fibrous, adherent, or calcified material (e.G., atherosclerotic plaque).".

• Brand Name: ARTIX MT THROMBECTOMY DEVICE, 4-8MM, 130CM
• 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: 24397414
• Report Number: 3020347218-2026-00012
• Device Sequence Number: 8579757
• Product Code: KRA
• UDI-Device Identifier: 00810123710591
• UDI-Public: (01)00810123710591(17)261114(10)25110074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 32-103
• Device Catalogue Number: 32-103
• Device Lot Number: 25110074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female