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

Model Number	52-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/15/2025
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 not provided, the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.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 stryker medical affairs, who concluded that the patient's injury was the result of user error.The device labeling includes vascular trauma (i.E., dissection, rupture, perforation, tear, etc.) as a potential complication.The device labeling includes the following warning: "do not attempt intri24 introducer sheath advancement without guidewire in place and dilator attached.Major bleeding, vessel damage, or serious injury to the patient, including death, may result" manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2025, a male patient underwent pulmonary embolism (pe) thrombectomy using inari devices.The patient had a saddle pe.During the thrombectomy, a large amount of blood had leaked from around the intri24 introducer sheath (intri24), therefore the medical team replaced the device with a new intri24, however the second intri24 experienced the same issue.The leak was noticed when the dilator was removed.When asked about the steps taken to place the intri24, the physician described floating the intri24 in the inferior vena cava (ivc) and introducing the sheath over the floating wire.The physician ran a catheter into the iliac artery near the entrance of the intir24 and injected contrast.The artery was intact with no signs of perforation.Then a sheath was introduced side-by-side with the intri24 and contrast was injected again, showing no signs of iliac or femoral vein extravasation.Contrast was then injected into the patient's ivc and slight extravasation was observed.The extravasation worsened when the dilator and intri24 were retracted.The intri24 was removed, and a balloon tamponade was placed to control the bleeding.The patient's vitals remained stable throughout the procedure.The thrombectomy was discontinued and the patient was transferred to a medical floor for observation.

• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 23296676
• Report Number: 3020347218-2025-00068
• Device Sequence Number: 9917460
• Product Code: DYB
• UDI-Device Identifier: 00850291007260
• UDI-Public: 00850291007260
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/14/2025

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: 09/15/2025
• Initial Report FDA Received Date: 10/15/2025
• 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: TRIEVER24
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male