MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13FR, 15CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	50-101
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a patient underwent a thrombectomy procedure using the clottriever system of devices.When inserting the sheath into the left popliteal vein, the funnel did not fully open.As such, an 8 x 40 balloon was used to expand the funnel successfully.The remainder of the case was performed the usual way performing a total of 3 passes.After the passes, an ivus catheter was used to determine clot clearance and look for compression of the left common iliac vein.A compression was noted and the physician determined he will stage it and bring back another time.A figure 8 suture was performed around the sheath and flowstasis was engaged for removal of sheath.Attempting to remove the sheath was not successful, as the sheath would not come out.Use of heparinized saline to coat the sheaths hydrophilic coating was attempted, skin nick was attempted, and inserting dilator while attempting to remove was attempted.Several venograms were performed to visualize the funnel and vein.The funnel and vein appeared normal in imaging.The patient was having pain during the removal attempts.A vascular surgeon was called to the room and determined the patient needed a cutdown of the popliteal vein to remove sheath.Once the cut down was performed staff sent pictures of the sheath which had been cut out of the popliteal vein as the vessel had ruptured and the funnels had became entangled into the vessel walls.
Additional Manufacturer Narrative
Manufacturing reference number: (b)(4).The suspect device will not be returned to the manufacturer.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 dr.(b)(6) on (b)(6) 2026.It was determined device entanglement was likely the result of likely vasospasm caused the device issue when retracting.The available information reasonably suggests the inari device likely contributed to the venous cutdown.Device labelling lists vasospasm and vessel dissection as possible adverse events with use of the device.

• Brand Name: CLOTTRIEVER SHEATH, 13FR, 15CM
• 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: 24756218
• Report Number: 3020347218-2026-00029
• Device Sequence Number: 18449133
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)271013(10)25100070
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 50-101
• Device Catalogue Number: 50-101
• Device Lot Number: 25100070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2025
• 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