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

Model Number	50-101
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to supplement an initial mdr mailed on 3/13/2026 due to a temporary system outage affecting the manufacturer's complaint handling system.Although this report is being submitted as an initial report due to system limitations, it is intended as a follow-up report to the previously submitted paper mdr (3020347218-2026-paper-03).The devices were discarded by the user facility and are not available for evaluation.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 the same issue has not been reported against this lot number.Manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2026 a patient underwent deep vein thrombosis (dvt) thrombectomy using stryker peripheral vascular devices.A total of six passes were performed using the clottriever catheter (ct catheter) through the clottriever sheath, 13fr (ct sheath).Following the sixth pass, the ct catheter was removed and while removing the ct sheath, it was noticed that the funnel was separated from the sheath and remained subcutaneous.The funnel was surgically removed.

• 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: 24653547
• Report Number: 3020347218-2026-00025
• Device Sequence Number: 6121084
• Product Code: QEW
• UDI-Device Identifier: 00810123710058
• UDI-Public: (01)00810123710058(17)270605(10)25060030
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 25060030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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