MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER BOLD CATHETER, 6-16MM, 12FR, 80CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	42-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	10/22/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided; however, the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.There was no report of any device malfunction.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari stryker medical affairs, who concluded that the patient¿s death was likely the result of inadvertent clot embolism.Distal embolization of blood clots is identified as a possible adverse event/complication in the device labeling.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 36-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had a history of pulmonary embolism (pe) and had a preexisting filter in his inferior vena cava (ivc).The patient underwent a pe thrombectomy in (b)(6) 2025.The patient had been incarcerated the month before the dvt thrombectomy, which lead to the patient discontinuing his eliquis prescription.The patient subsequently developed clot in his ivc filter that extended to his bilateral veins below.The patient ivc filter was removed via the internal jugular vein (ij) and was then positioned supine for the remaining dvt thrombectomy.Four passes were completed on the left and six on the right using the clottriever bold catheter (ct bold).At the completion of the procedure, while the access site was being closed, the patient began to decompensate.A code was called, and the critical response team attempted to resuscitate the patient for eighty minutes; however, the patient ultimately expired.

• Brand Name: CLOTTRIEVER BOLD CATHETER, 6-16MM, 12FR, 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: 23609440
• Report Number: 3020347218-2025-00079
• Device Sequence Number: 9765612
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230494
• 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): 11/20/2025

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: 42-102
• Device Catalogue Number: 42-102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Age: 36 YR
• Patient Sex: Male