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	02/21/2025
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, a female patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 60 days.During the thrombectomy, the radiopaque tip of the revcore thrombectomy catheter (revcore) had separated from the catheter.A protrieve sheath aspirated the tip through the patient's internal jugular vein.The protrieve sheath with the collected radiopaque tip were removed from the patient.The case was completed without further issues.
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) was returned to the manufacturer and evaluated.Visual inspection confirmed the radiopaque tip had separated from the catheter and no other signs of damage or defects were observed.The tip and area of the catheter shaft which the tip is adhered to were reviewed under magnification.Cured adhesive was observed on both of the mating surfaces.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.As there was appropriate adhesive observed in the correct locations and no abnormalities were noted in the device history records, the tip of the revcore most likely separated due to the device being caught in torturous patient anatomy.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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 21654930
• Report Number: 3020347218-2025-00020
• Device Sequence Number: 7480399
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: (01)00850291007383(17)260301(10)24020130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/30/2025

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: 03/01/2026
• Device Model Number: 44-101
• Device Lot Number: 24020130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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.; CLOTTRIEVER SHEATH (13 FR).; FLOWSAVER.; PROTRIEVE SHEATH.; TRIEVER16 CATHETER.; VENACORE CATHETER.
• Patient Sex: Female