MAUDE Adverse Event Report: INARI MEDICAL, INC. INTHRILL THROMBECTOMY CATHETER, 4-10MM, 8FR, 65CM

Model Number	43-102
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On, (b)(6) 2026, a patient underwent an av graft declot procedure using the in thrill device.During the procedure, the device was interfered with and deformed by an existing stent.The dr was able to apply another stent, complete the procedure, and the patient did not experience any adverse events or injury as a result.
Additional Manufacturer Narrative
The device was not returned thus the failure mode was not confirmed through failure analysis.There was no indication that the product malfunctioned, and no product was returned for investigation.Manufacturing record, complaint and capa reviews showed no issues related to this complaint.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.This issue is an anticipated risk that is documented in the instructions for use: the instructions for use for the in thrill thrombectomy catheter; iu-01008_rev.E_en_2023-03-17; contains the following warning: when the in thrill thrombectomy catheter is in the path of an exposed stent, damage to the stent, the coring element, or dislodgment of the stent, etc.May occur.

• Brand Name: INTHRILL THROMBECTOMY CATHETER, 4-10MM, 8FR, 65CM
• Common Device Name: THROMBECTOMY CATHETER
• 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: 25175047
• Report Number: 3020347218-2026-00038
• Device Sequence Number: 10566845
• Product Code: QEW
• UDI-Device Identifier: 00810123710126
• UDI-Public: 00810123710126
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250421
• 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): 05/14/2026

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
• Device Model Number: 43-102
• Device Catalogue Number: 43-102
• Device Lot Number: 25120024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2025
• 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 Sex: Unknown