MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 16 FR; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	51-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clottreiver sheath, 16fr (ct sheath) was returned to the manufacturer and investigated.Visual inspection revealed tissue covering the funnel.The tissue was removed from the device and no signs of damage or defects were observed on the sheath shaft or funnel.The patient's vessel damage was likely due to excessive force used to advance/retract the device against resistance, possibly exasperated by patient anatomy and/or navigating a torturous insertion pathway.Two lots were provided, that could be the lot with the failure.Both lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted for both lots and no similar issues have been reported against either lot number.The device labeling includes the following warning: "avoid using excessive force to advance or retract the clottriever sheath and dilator against resistance.If excessive resistance is encountered, remove the device.Excessive force against resistance may result in damage to the clottriever sheath and dilator and/or vessel." the device labeling includes the following precaution: "ultrasound guidance should be used to ensure desired vessel target area is accessed during introducer sheath placement." vessel dissection is listed in the device labeling as a possible adverse event/complication.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2025, a female patient underwent bilateral popliteal deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had a preexisting left lower extremity stent that had occluded.During the procedure, the left popliteal vein was accessed without issue using the clottreiver sheath, 16fr (ct sheath) and revcore catheter.Upon moving to the right popliteal vein, access was attempted by inserting the ct sheath.Initial attempts on the right side encountered a network of collateral veins.Two separate attempts appeared to have entered a collateral based on wire trajectory and venography.Intravascular ultrasound (ivus) was not used to confirm the location.The procedure continued without any apparent intraprocedural complications.No thrombectomy was performed through the right side access, only deployment of the flowtriever xl catheter disks.Upon removal of the ct sheath, at the conclusion of the procedure, tissue resembling vein wall was adherent to the sheath.The physician stated that the vessel may have externalized with the sheath removal, and the physician excised the tissue.The access site was closed with sutures and manual pressure was held.There was no bleeding or hematoma identified at the time of closure.Upon reviewing the venography post-procedure, it was discussed that the access may have been in a collateral vein.Follow up the next day post-procedure, indicated that the patient was stable without any reported complications.

• Brand Name: CLOTTRIEVER SHEATH, 16 FR
• 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 ; 8779234747
• MDR Report Key: 23538441
• Report Number: 3020347218-2025-00076
• Device Sequence Number: 11967878
• Product Code: QEW
• UDI-Device Identifier: 00850291007123
• UDI-Public: 00850291007123
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233815
• 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): 11/12/2025

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: 51-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: FLOWTRIEVER XL CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female