MAUDE Adverse Event Report: INARI MEDICAL, INC. REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	44-101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is in transit to the manufacturer.Upon receipt of the device a full evaluation will be completed.Manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2025, a 54-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.During the thrombectomy, the radiopaque tip of the revcore thrombectomy catheter (revcore) detached from the catheter.The radiopaque tip remained on the guidewire and was able to be successfully removed.The procedure was completed without further issues.
Event or Problem Description
On (b)(6) 2025, a 54-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.During the thrombectomy, the radiopaque tip of the revcore thrombectomy catheter (revcore) detached from the catheter.The radiopaque tip remained on the guidewire and was able to be successfully removed.The procedure was completed without further issues.
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) was returned to the manufacturer and evaluated.Visual inspection confirmed the revcore distal tip had separated from the catheter.The tip and catheter were observed under microscopic imaging, which revealed cured adhesives on both mating surfaces.As cured adhesive was observed, the failure is unlikely the result of deficiencies in the manufacturing process.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 tip separated at the customer's site likely due to excessive force applied to the device while the device was likely caught in particularly torturous anatomy.The device labeling includes the following warning: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." the manufacturer's reference number: (b)(4).

• Brand Name: REVCORE THROMBECTOMY CATHETER, 6-20MM, 12FR, 80CM
• 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: 23619198
• Report Number: 3020347218-2025-00081
• Device Sequence Number: 9072234
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: (01)00850291007383(17)260228(10)24020117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 44-101
• Device Catalogue Number: 44-101
• Device Lot Number: 24020117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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
• Patient Age: 54 YR
• Patient Sex: Male