MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER BOLD CATHETER; 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	08/10/2025
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 provided, and the lot history records 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 potentially the result of inadvertent clot embolism.Manufacturer reference #: (b)(4).
Event or Problem Description
A cancer patient presented to the emergency department with iliofemoral and inferior vena cava thrombus.The decision was made to use the clottriever bold catheter (ct bold) to clear the thrombus and restore flow.The patient also had a pre-existing pulmonary embolism that did not have a plan for treatment.The first pass with the ct bold yielded "white jelly type" clot.The second pass yielded the same thing.At this time, the patient deteriorated and experienced a loss in blood pressure and o2 saturation.It was presumed that clot may have embolized into the lungs.A code was called, and cardiopulmonary resuscitation was initiated.A faint pulse was obtained.Extracorporeal membrane oxygenation was brought in, but the patient was listed as "do not resuscitate".The patient expired on the table.

• Brand Name: CLOTTRIEVER BOLD CATHETER
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; irvine, CA 92618 ; 9493744235
• MDR Report Key: 23009680
• Report Number: 3020347218-2025-00058
• Device Sequence Number: 21453782
• Product Code: QEW
• UDI-Device Identifier: 00810123710393
• UDI-Public: (01)00810123710393(17)270418(10)25040090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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 Lot Number: 25040090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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; Life Threatening
• Patient Sex: Unknown