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

Model Number	30-103
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The artix thin-walled sheath (artix sheath) with the terumo destination sheath still in place, artix funnel catheter, and artix mechanical thrombectomy catheter (mt) were returned to the manufacturer for investigation.The artix sheath had score marks from the externalized stent throughout the inner diameter of the sheath, but no ptfe liner delamination.Stress/compression of the pebax was identified on both sides of the sheath damage (reported uncoupling).There was damage at the tip noted as well.The mt had damage identified on the delivery catheter shaft and tip, and element catheter that was consistent with damage caused by excessive force.The returned artix funnel catheter had no damage identified.Based on the investigation, the artix sheath damage was likely the result of excessive force required to release the mt from the patient's pre-existing stent as well as the removal of the stent fragments.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 device labeling includes the following warning statements: "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." "never advance or torque the artix sheath against resistance without careful assessment of cause of resistance using fluoroscopy." the device labeling includes the following precaution: "use caution when manipulating or advancing the artix sheath through a stent or graft." manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025 a 58-year-old male patient underwent left lower extremity (lle) arterial thrombectomy using inari devices.The patient had a pre-existing stent in the left popliteal artery that was placed approximately one year prior.During the thrombectomy, the artix thin-walled sheath (artix sheath) accessed the treatment location through the patient's right common femoral artery.During a pass with the artix mechanical thrombectomy catheter (mt), the mt became stuck on the patient's pre-existing stent.The physician was able to successfully dislodge the mt from the stent by using force to pull the catheter.The mt was unable to collaps into the artix funnel catheter (funnel catheter) and both the mt and funnel catheter were removed in tandem through the artix sheath.Upon removal of the mt, it was noted stent fragments were captured in the collection bag.A 6fr terumo destination sheath was introduced through the artix thin-walled sheath (artix sheath) to retrieve the remaining stent piece that was distal to the artix sheath.Upon completion of the case, the terumo destination sheath became stuck in the artix sheath.The artix sheath became kinked and uncoupling was observed distal to the strain relief.The physician created a larger skin nick and removed the terumo destination sheath and the artix sheath together with the remaining stent piece.There was no injury to the patient.

• Brand Name: ARTIX THIN-WALLED SHEATH
• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 21712038
• Report Number: 3020347218-2025-00022
• Device Sequence Number: 10130724
• Product Code: KRA
• UDI-Device Identifier: 00810123710560
• UDI-Public: (01)00810123710560(17)250425(10)24100145
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: 04/25/2025
• Device Model Number: 30-103
• Device Lot Number: 24100145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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 AX ASPIRATION CATHETER; ARTIX COVERED FUNNEL CATHETER; ARTIX MECHANICAL THROMBECTOMY CATHETER
• Patient Age: 58 YR
• Patient Sex: Male