MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13FR, 15CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	50-101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.During the procedure, the clottriever sheath, 13 fr.(ct sheath) was removed from the patient to flush the device and then was reintroduced into the patient.After reinsertion, the ct sheath was pulled back a few centimeters and the hemostasis valve separated from the sheath shaft.Wire access was still maintained.The physician performed a larger skin nick and the sheath shaft was able to be successfully removed from the patient's vasculature using hemostats.The sheath shaft and funnel remained intact.The procedure was resumed without further incident.
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)(6).
Additional Manufacturer Narrative
The clottriever sheath was returned to the manufacturer and evaluated.Visual examination found that the clottriever sheath shaft was separated from the hemostasis valve only attached by a wire.The cause of the clottriever sheath shaft separation was most likely due to procedural factors such as excessive manipulation during use.Application of excessive force used to advance/retract the device against resistance.Excessive force can cause damage to the sheath and in this case is undetermined as to the exact reason why but can be related to patient anatomy and/or tortuous insertion pathway.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.There was no patient harm; however, the information reasonably suggest that the device has malfunctioned and that if this malfunction were to recur it may cause or contribute to a death or serious injury.Per the clottriever sheath instructions for use (iu-01098_rev.B_2025-08-07), "warnings: avoid using excessive force to advance or retract the clottriever sheath and dilator against resistance.If excessive resistance is encountered, remove the device.Excessive force against resistance may result in damage to the clottriever sheath and dilator and/or vessel." manufacturer reference number is (b)(4).
Event or Problem Description
On (b)(6) 2026, a patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.During the procedure, the clottriever sheath, 13 fr.(ct sheath) was removed from the patient to flush the device and then was reintroduced into the patient.After reinsertion, the ct sheath was pulled back a few centimeters and the hemostasis valve separated from the sheath shaft.Wire access was still maintained.The physician performed a larger skin nick and the sheath shaft was able to be successfully removed from the patient's vasculature using hemostats.The sheath shaft and funnel remained intact.The procedure was resumed without further incident.

• Brand Name: CLOTTRIEVER SHEATH, 13FR, 15CM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• 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: 24507757
• Report Number: 3020347218-2026-00017
• Device Sequence Number: 10416207
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)270611(10)25060057
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K233815
• 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): 04/29/2026

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 Model Number: 50-101
• Device Catalogue Number: 50-101
• Device Lot Number: 25060057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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
• Patient Sex: Male