MAUDE Adverse Event Report: INARI MEDICAL, INC. - MHRA ORG ID:14354 TRIEVER16, 16FR, 107CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy procedure using the clottriever system of devices.The distal portion of the catheter separated and required additional devices to remove it intravascularly.
Additional Manufacturer Narrative
The suspect device will not be returned to the manufacturer and as such will not be evaluated.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.There are no nonconformances or capas relating to this complaint issue.There was no patient harm, however the information reasonably suggests that the device has malfunctioned and that if this malfunction were to recur it may cause or contribute to a death or serious injury.

• Brand Name: TRIEVER16, 16FR, 107CM
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC. - MHRA ORG ID:14354; 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: 25319084
• Report Number: 3020347218-2026-00043
• Device Sequence Number: 17456604
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: (01)00850291007130(17)27111(10)25110043
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K211013
• 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
• Report Date (Section B): 05/28/2026

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: 25-101
• Device Catalogue Number: 25-101
• Device Lot Number: 25110043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• 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 Sex: Unknown