MAUDE Adverse Event Report: INARI MEDICAL, INC. VENACORE THROMBECTOMY CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	46-101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a 63-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The clot age was estimated at 28 days.At the end of the thrombectomy, while the venacore catheter (venacore) was being prepped for the sixth catheter pass, a strut on the coring element was noted broken.Another device was opened to complete the case.There was no injury to the patient and all devices and components were completely removed from the patient.
Additional Manufacturer Narrative
The venacore catheter was discarded by the user facility and is not available for evaluation.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: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, collapse, and retract 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: VENACORE 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: 21886782
• Report Number: 3020347218-2025-00028
• Device Sequence Number: 8189948
• Product Code: QEW
• UDI-Device Identifier: 00850291007406
• UDI-Public: (01)00850291007406(17)261105(10)24110017
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K234034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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 Model Number: 46-101
• Device Lot Number: 24110017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 96 KG