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

Model Number	51-101
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025, an 80-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at two days.During the thrombectomy, the clottriever sheath, 16 fr (ct sheath) was placed in the right popliteal vein access site.The funnel on the ct sheath was deployed appropriately but prior to retracting the dilator, the slides were pulled towards to proximal end.Resistance was felt, so the slides were pushed back down.Resistance was felt again, and the funnel was observed deforming on imaging.An attempt was made to remove the sheath, but the patient's skin was wrapped around the funnel and dilator.A larger skin nick was performed, and the dilator and funnel were able to be separated.Upon removing the device, the funnel was deformed, and the dilator had cracked.The medical team observed the area of dissection for several minutes to ensure the area did not get larger.Once the team confirmed the area did not get worse and that the patient did not require any additional medical intervention to resolve the vessel injury, another clottriever sheath, 16 fr was used to complete the case.
Additional Manufacturer Narrative
The clottriever sheath, 16 fr (ct sheath) was returned to the manufacturer and evaluated.Visual inspection revealed that the funnel was damaged, and the dilator braid cover was frayed and damaged.The braid cover had some sharp edges; however, no signs of metal or wire were protruding from the dilator.When the dilator was pulled back to attempt to remove it from the sheath, the dilator braid cover became caught at the distal end of the sheath.This occurred both when the dilator handle slide actuator was in the forward and backward position.The dilator had to be cut to be removed from the sheath.An undamaged lab dilator was deployed and retracted through the returned sheath without issue.There was no sign of damage to the inside of the sheath shaft or garrote valve.The dilator braid cover was measured with calibrated calipers and measured within specification for outer diameter and wall thickness.The damage was likely caused by the dilator handle slide actuator being in the backwards position when the sheath was being removed from the patient.This likely caused the open braid cover to catch on either the sheath funnel, the garrote valve septum, the sheath shaft, or the access site during removal.If the braid cover catches on any of these areas, excessive force could result in the braid cover collapsing, compressing, or being damaged.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 device labeling includes the following instruction: "4.Push the dilator slide actuator forward until it snaps in place.While depressing the sheath's hub buttons, unsnap the dilator handle from the sheath hub and withdraw the dilator from the sheath." 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." vessel dissection and vessel perforation are listed in the device labeling as complications / adverse events.Manufacturer reference#: (b)(4).

• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 22072464
• Report Number: 3020347218-2025-00034
• Device Sequence Number: 9500868
• Product Code: QEW
• UDI-Device Identifier: 00850291007123
• UDI-Public: (01)00850291007123(17)261107(10)24110039
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 51-101
• Device Lot Number: 24110039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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: CLOTTRIEVER BOLD CATHETER.; TRIEVER20 CATHETER.
• Patient Age: 80 YR
• Patient Sex: Male