MAUDE Adverse Event Report: INARI MEDICAL, INC. INTRI24 INTRODUCER SHEATH, 24FR, 33CM; INTRODUCER, CATHETER

Model Number	52-101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 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.Additionally, a complaint history review was conducted, and no similar issues have been reported against this lot number.The case was reviewed by the stryker peripheral vascular (pv) medical affairs team, and it was concluded that the patient's blood loss, need for blood transfusion, and deterioration were likely the result of the device leak.Blood loss is listed as a potential adverse event/complication in the device labeling.Manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2026 a patient underwent pulmonary embolism (pe) thrombectomy using inari devices.The patient was a subject in the perserve clinical trial.During the thrombectomy, clot was stuck in the triever24 (t24) where the device had to be removed from the patient to remove the clot from the device.It was noticed that the intri24 introducer sheath (intri24) leaked when the t24 was removed from the intri24 and t24 was removed several times during the procedure to clean clot from the device.This leakage led to bleeding where the patient required a transfusion of two units of blood.The site also noted the patient suffered pre-procedure hypotension and desaturation which resulted in low blood pressure during the thrombectomy which resolved with medication and the patient also suffered cardiac arrest and was treated with medication intervention.

• Brand Name: INTRI24 INTRODUCER SHEATH, 24FR, 33CM
• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 24524394
• Report Number: 3020347218-2026-00019
• Device Sequence Number: 9704198
• Product Code: DYB
• UDI-Device Identifier: 00850291007260
• UDI-Public: (01)00850291007260(17)270724(10)25070130
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 52-101
• Device Catalogue Number: 52-101
• Device Lot Number: 25070130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2025
• 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: Required Intervention
• Patient Sex: Unknown