MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER CATHETER, 6-16MM, 11FR, 80CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	40-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	02/09/2026
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-04).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.The stryker peripheral vascular medial affairs team determined the patient's deterioration was likely the result of inadvertent clot embolism.The device labeling includes distal embolization of blood clots as a possible adverse event/complication.Manufacturer reference number: (b)(6).
Event or Problem Description
On (b)(6) 2026, a 60-year-old female patient underwent a thrombectomy procedure using the clottriever system of devices.After completing the first pass and cleaning the clottriever catheter, the patient deteriorated.Percutaneous cardiopulmonary support (pcps) was initiated and the patient's condition improved.Contrast enhanced computed tomography (ct) imaging revealed a mild pulmonary embolism (pe) the following day, the patient was weaned off pcps.Three days following the procedure, the patient was transferred to a general ward and began rehabilitation.One week following the thrombectomy, ct imaging showed remarkable improvement in both the patient's dvt and pe.The patient was scheduled for discharge on (b)(6) 2026.

• Brand Name: CLOTTRIEVER CATHETER, 6-16MM, 11FR, 80CM
• 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: 24654450
• Report Number: 3020347218-2026-00026
• Device Sequence Number: 5726278
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: (01)00850291007093(17)271106(10)25110026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221531
• 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): 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?: No
• Operator of Device: Health Professional
• Device Model Number: 40-102
• Device Catalogue Number: 40-102
• Device Lot Number: 25110026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2025
• 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; Hospitalization
• Patient Sex: Unknown