MAUDE Adverse Event Report: INARI MEDICAL, INC. REVCORE THROMBECTOMY CATHETER; 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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) ,2025, a 46-year-old male underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 20 days.During the thrombectomy, while removing the revcore catheter from the patient, the radiopaque tip separated from the catheter but remained on the guidewire.The physician was able to be advanced and out of the patient's body through the protrieve sheath that was in the patient's right internal jugular vein.The patient did not experience any injury during the procedure.The procedure was completed and approximately 85% of the patient's clot was removed.
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).
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) was returned to the manufacturer and evaluated.Visual inspection of the device confirmed the tip had separated, and visual inspection revealed additional damage at the proximal hub, where the cap experienced separation.The tip was not returned with the remaining device.Images were taken of the inner catheter shaft, where the tip adhered to which revealed cured adhesive on the mating surfaces.As cured adhesive was observed, the failure is unlikely the result of deficiencies in the manufacturing process.An unopened device from the same lot was also returned and tested.Tensile testing was completed on the tip.The device passed production tensile testing.The tip separated likely due to the device being caught in particularly torturous anatomy which challenged the adhesive bond.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 warning statements: "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." manufacturer reference #: (b)(4).

• Brand Name: REVCORE THROMBECTOMY CATHETER
• 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: 22856326
• Report Number: 3020347218-2025-00053
• Device Sequence Number: 13008556
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: (01)00850291007383(17)260924(10)24090109
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K223609
• 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): 10/30/2025

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: 09/24/2026
• Device Model Number: 44-101
• Device Lot Number: 24090109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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 SHEATH, 16FR.; FLOWSAVER.; PROTRIEVE SHEATH.; TRIEVER16.
• Patient Age: 46 YR
• Patient Sex: Male