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 Codes	Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	04/05/2024
Type of Reportable Event	Death
Event or Problem Description
An 81-year-old female patient presented to the emergency department with left leg pain and swelling but was discharged after a venous duplex was inconclusive for deep vein thrombosis (dvt).The patient returned to the emergency department 2 days later due to increasing leg pain, swelling, and skin color changes.Another venous duplex was performed which revealed iliofemoral dvt in the lower left extremity (lle).The patient was given intravenous heparin and a dvt thrombectomy was scheduled for the next morning.The clot age was estimated at 5 days.Prior to the procedure, the patient received a blood transfusion for anemia (unknown etiology) under conscious sedation (versed 1 mg and fentanyl 25 mcg).A venogram revealed an open left popliteal vein with occlusive clot starting in the middle femoral vein.Wire positioning was obtained and the inari clottriever bold catheter was used to perform a single pass which yielded acute/sub-acute clot.A second pass was performed, and an additional 25 mcg of fentanyl was administered after the patient reported feeling the catheter pass.Before the third pass was performed, the patient began to decompensate.Opioid reversal drugs were called for and the third pass was completed.However, the patient remained unresponsive and a code was initiated.Cardiopulmonary resuscitation was initiated, and the patient was intubated.Once the patient stabilized they were transferred to the intensive care unit, but vitals signs were poor.Unfortunately, there was no sign of improvement and the family elected to discontinue life preserving measures and the patient died later that day.Additional patient follow-up was requested to better understand the source of the clinical deterioration.Echo revealed severe right ventricular dysfunction, suggestive of a pulmonary embolism; however, this diagnosis was not confirmed with imaging.
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's chief medical officer, who concluded that the patient's deterioration was likely the result of inadvertent clot embolism.Distal embolization of blood clots and cardiovascular collapse are identified in the device labeling as possible adverse events/complications.Manufacturer 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 19244278
• Report Number: 3020347218-2024-00022
• Device Sequence Number: 15190947
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 Expiration Date: 12/11/2025
• Device Model Number: 42-102
• Device Lot Number: 23120038
• 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: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: CT SHEATH 13 FR; GLIDEWIRE ADVANTAGE
• Outcome Attributed to Adverse Event: Death; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female