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	01/24/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 no similar issues have been reported against this lot number.The case was reviewed by stryker's peripheral vascular (pv) medical affairs team, and it was concluded that the patient's death was likely the result of inadvertent clot embolism.Distal embolization of blood clots is listed in the device labeling as a possible adverse event/complication.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2026 a patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient was intubated and positioned prone for the procedure.The patient's left popliteal vein was accessed and initial venogram showed clot extending from the patient's femoral vein to their common iliac vein.The clottriever bold catheter (ct bold) was deployed into the patient's inferior vena cava (ivc).While cleaning the ct bold after a pass, it was noted that the patient's end-tidal carbon dioxide (etco2) decreased and the patient had ectopic heartbeats.The physician ensured the guidewire was not in the heart via fluoroscopy.However the patient continued to deteriorate.The physician then took images of the patient's proximal common iliac and ivc and no clot was observed in the image and contract in the ivc was not clearing.The patient was then flipped supine and resuscitation efforts began.Cpr with defibrillation was administered as well as intravenous tissue plasminogen activator (tpa); however, despite resuscitation efforts the patient 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: 24394499
• Report Number: 3020347218-2026-00011
• Device Sequence Number: 21297742
• Product Code: QEW
• UDI-Device Identifier: 00810123710393
• UDI-Public: (01)00810123710393(17)271006(10)25100022
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/19/2026

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: 42-102
• Device Catalogue Number: 42-102
• Device Lot Number: 25100022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: Death
• Patient Sex: Unknown