MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER XL CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	41-102
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
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, or design.The case was reviewed by inari's chief medical officer, who concluded that the patient's deterioration was the result of inadvertent clot embolism.Manufacturer reference #: (b)(4).Distal embolization of blood clots is identified in the device labeling as possible adverse events/complications.
Event or Problem Description
A male patient underwent a thrombectomy with the clottriever xl catheter (ctxl).Access was obtained in the right internal jugular and the protrieve sheath was placed.Two passes were performed which removed clot burden.However, on the third pass the ctxl became overloaded and the mid to distal portion of the collection bag became stuck in the protrieve basket.A protrieve aspiration was performed and the protrieve was removed with the ctxl while under aspiration.The patient then began to decompensate with a drop in their oxygen saturation and heart rate.Chest compressions were performed, and the patient was prepped for a pulmonary embolism thrombectomy.A code was called with additional chest compressions.The patient was agitated and began moving which led to anesthesia to intubate the patient.Crossing the right heart was difficult due to the chest compressions but eventually an aspiration was performed in the right pulmonary artery.A large clot burden was aspirated which was acute-on-chronic.The procedure continued and one modest sized clot was removed from the left pulmonary artery.Final imaging revealed that both lobes filled completely.The patient was placed on extracorporeal membrane oxygenation and was transferred to another facility.The patient was last reported to have been awake and responding to prompts.The patient was eventually placed back under sedation to control his vitals.

• Brand Name: CLOTTRIEVER XL 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: 20017755
• Report Number: 3020347218-2024-00037
• Device Sequence Number: 12631635
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223210
• 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): 08/15/2024

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
• Device Expiration Date: 04/29/2026
• Device Model Number: 41-102
• Device Lot Number: 24040125
• 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: 07/17/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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: FLOWSAVER; INTRI24 SHEATH; PROTRIEVE SHEATH; TRIEVER24
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male