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	04/18/2025
Type of Reportable Event	Death
Event or Problem Description
A 72-year-old female underwent a thrombectomy with inari devices to address her deep vein thrombosis.The patient had clot ranging from the femoral vein into the inferior vena cava (ivc).The plan was to perform the procedure without embolic protection.Wire positioning was obtained without issue and a clottriever bold catheter was advanced into place after a 13 fr clottriever sheath was inserted.3 passes were performed then the vitals machine stopped picking up the patient's oxygen saturation.The patient then became tachycardic and began having premature ventricular contractions.The procedure was aborted in attempts to stabilize the patient.A rapid response was initiated, and a code was called soon after.Cardiopulmonary resuscitation was conducted for 45 minutes before the patient's family decided to discontinue it.The patient expired.Follow-up information revealed that the patient's initial computed tomography scan showed a small distal pulmonary embolism, the physician decided not to intervene.The physician also indicated that the patient's deterioration could potentially be the result of sedation and/or clot being sent to the pulmonary arteries.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided; 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's chief medical officer, who concluded that the patient's death may have been the result of inadvertent clot embolism.Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.The manufacturer's reference #: (b)(4).

• Brand Name: CLOTTRIEVER BOLD CATHETER
• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 22037973
• Report Number: 3020347218-2025-00030
• Device Sequence Number: 8112167
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/16/2025

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
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOTTRIEVER SHEATH, 13 FR
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female