MAUDE Adverse Event Report: INARI MEDICAL, INC. INTHRILL SHEATH, 8FR, 6CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	53-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/10/2025
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, however, the lot history records of all potential lots were reviewed and 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 team, who concluded that the inari devices could not be ruled out as contributory to the event.The device labeling includes vessel dissection and vessel perforation as potential complications.Manufacturer reference # (b)(4).
Event or Problem Description
On (b)(6) 2025, a patient underwent upper extremity deep vein thrombosis thrombectomy using inari devices.During the procedure, the physician had difficulty angling the inthrill sheath due to the patient's preexisting arteriovenous graft.Contrast extravasation was noticed on fluoroscopy around the anastomosis.The extravasation was treated with implanting a stent graft.Final imaging showed good blood flow through the graft.
Additional Manufacturer Narrative
G1 "reporting contact" should read "(b)(4).
Event or Problem Description
On (b)(6) 2025, a patient underwent upper extremity deep vein thrombosis thrombectomy using inari devices.During the procedure, the physician had difficulty angling the inthrill sheath due to the patient's preexisting arteriovenous graft.Contrast extravasation was noticed on fluoroscopy around the anastomosis.The extravasation was treated with implanting a stent graft.Final imaging showed good blood flow through the graft.

• Brand Name: INTHRILL SHEATH, 8FR, 6CM
• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 23500024
• Report Number: 3020347218-2025-00077
• Device Sequence Number: 13038058
• Product Code: QEW
• UDI-Device Identifier: 00850291007369
• UDI-Public: 00850291007369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K223613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 53-101
• Device Catalogue Number: 53-101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown