MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13FR, 15CM; THROMBECTOMY WIRE-NET INTRODUCTION SET

Model Number	50-101
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Vascular Dissection (3160); Foreign Body Embolism (4439)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returned to the manufacturer.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.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy procedure using the clottriever system of devices.Access via guidewire was established.The clottriever sheath was inserted.The procedure was going smoothly until the patient felt pain.X-ray was utilized to obtain visualization and a clinical support staff member noticed the end of the sheath¿s funnel was slightly curved.The patient was supine, in a frog-leg position.The doctor decided to remove the clottriever sheath to check it.There was not much resistance felt by the surgeon when removing the sheath, but upon inspection, the funnel was missing.The doctors performed a venous cutdown to remove the funnel and then closed the right popliteal access.

• Brand Name: CLOTTRIEVER SHEATH, 13FR, 15CM
• Common Device Name: THROMBECTOMY WIRE-NET INTRODUCTION SET
• 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: 24501599
• Report Number: 3020347218-2026-00015
• Device Sequence Number: 10115373
• Product Code: QEW
• UDI-Device Identifier: 00810123710058
• UDI-Public: (01)00810123710058(17)270418(10)25040097
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: 50-101
• Device Catalogue Number: 50-101
• Device Lot Number: 25040097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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: 36 YR
• Patient Sex: Male