MAUDE Adverse Event Report: INARI MEDICAL, INC. ARTIX THIN-WALLED SHEATH, 8FR, 90CM

Model Number	30-104
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
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 79-year-old male patient underwent arterial thrombectomy using inari devices.The patient had a preexisting stent in the right superficial artery.The patient¿s clot age was estimated at seven days, and the occlusion was in the patient¿s right superficial artery.Upon completion of the thrombectomy, a balloon was inserted into the artix thin-walled sheath (artix sheath) for post-thrombectomy angioplasty.A lot of tension was noted upon initially deploying the artix sheath.While the physician was ballooning, the physician pulled back on the artix sheath and the sheath unraveled and collapsed on the inflated balloon.This prevented the balloon from deflating and was subsequently stuck within the sheath.The physician performed an arterial cutdown and was able to successfully remove both the artix sheath and balloon.
Event or Problem Description
On (b)(6) 2025, a 79-year-old male patient underwent arterial thrombectomy using inari devices.The patient had a preexisting stent in the right superficial artery.The patient¿s clot age was estimated at seven days, and the occlusion was in the patient¿s right superficial artery.Upon completion of the thrombectomy, a balloon was inserted into the artix thin-walled sheath (artix sheath) for post-thrombectomy angioplasty.A lot of tension was noted upon initially deploying the artix sheath.While the physician was ballooning, the physician pulled back on the artix sheath and the sheath unraveled and collapsed on the inflated balloon.This prevented the balloon from deflating and was subsequently stuck within the sheath.The physician performed an arterial cutdown and was able to successfully remove both the artix sheath and balloon.
Additional Manufacturer Narrative
The device was returned to the manufacturer and investigated.Visual inspection of the artix-thin walled sheath (artix sheath) confirmed the sheath shaft had separated in two different locations.The separations exposed the inner coil.Delamination proximal to the break was also observed.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.Investigation concluded the device separated likely as a result of excessive force used to advance/retract the device against resistance.The device labeling includes the following warning statement: "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." manufacturer reference number: (b)(4).

• Brand Name: ARTIX THIN-WALLED SHEATH, 8FR, 90CM
• Common Device Name: ARTIX THIN-WALLED SHEATH
• 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: 23598169
• Report Number: 3020347218-2025-00078
• Device Sequence Number: 9337459
• Product Code: KRA
• UDI-Device Identifier: 00810123710577
• UDI-Public: (01)00810123710577(17)260728(10)25070151
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/11/2025

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 Expiration Date: 07/28/2026
• Device Model Number: 30-104
• Device Catalogue Number: 30-104
• Device Lot Number: 25070151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG