MAUDE Adverse Event Report: INARI MEDICAL, INC. INTRI24 INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	52-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2025
Type of Reportable Event	Death
Event or Problem Description
An 85-year-old female arrived at the hospital with shortness of breath and chest pain.The patient had a history of cardiac issues and was listed as "do not resuscitate".The patient was diagnosed with massive pulmonary embolism and a thrombectomy was performed with inari devices.The patient was intubated and on two pressors at the beginning of the thrombectomy.The procedure began without issues and a large amount of clot was removed from the patient's right side through five aspirations with the triever20 (t20).The patient's oxygen (o2) saturation rose, and imaging revealed that the right side was clear.The physician re-positioned to the left and was in process of obtaining wire positioning when a nurse noticed a large volume of blood on the ground.Upon further investigation, the stopcock of the large bore syringe side port was not closed after imaging was performed.It was estimated that there was 500 cc of blood lost from the side port being left open.This was in addition to 300 cc of blood loss from aspirations leading to a total of approximately 800 cc of blood loss.The patient's blood pressure and o2 declined.The physician managed to re-position to the left side while an order of blood was processing.Two further aspirations were performed which cleared some clot.Flowsaver was used to return blood.Fluid and blood were administered to the patient.The physician performed two additional aspirations but was unable to fully clear the left side.At the time the procedure was concluded, and the patient was transferred to the intensive care unit.The patient passed away in the middle of the night.
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 was the result of severe disease state and user error (blood loss due to failure to close the side port stopcock).Blood loss, bleeding, and death are listed as potential complications/adverse events.Manufacturer reference #: (b)(4).

• Brand Name: INTRI24 INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• 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: 21579947
• Report Number: 3020347218-2025-00016
• Device Sequence Number: 8757595
• Product Code: DYB
• UDI-Device Identifier: 00850291007260
• UDI-Public: 00850291007260
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K233646
• 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): 03/11/2025

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: 52-101
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/11/2025
• 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: AMPLATZ SUPER STIFF GUIDEWIRE; FLOWSAVER; TRIEVER20; TRIEVER24
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Death
• Patient Age: 85 YR
• Patient Sex: Female