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

Model Number	46-101
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	02/25/2025
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 19 days.During the thrombectomy, the coring element of the venacore catheter (venacore) was not fully collapsed while removing from the patient, which resulted in additional force used to remove the device from the patient.Upon removal of the venacore from the patient, the medical team noticed a strut on the coring element had broken off.Nothing was left inside the patient, and the patient did not endure any injury.
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 venacore catheter (venacore) was returned to the manufacturer and evaluated.The catheter was returned sheathed with the delivery catheter enclosing the distal coring element.The element catheter struggled to unsheathe from the delivery catheter and only did so when a large amount of force was applied due to the broken strut snagging on the internal lining of the delivery catheter.Examination of the expanded coring element identified the broken strut as well as bending/deformation on the neighboring struts.An attempt was made to pull the delivery catheter over the expanded element.The delivery catheter was only able to capture a small portion of the proximal coring element struts, and it caused the remaining exposed struts to balloon outwards.The maximum travel of the delivery catheter matched up to the deformation on the neighboring element struts.Attempting to sheath the element catheter while the element was in the expanded state likely caused the strut to break.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 instructions: "at the end of the procedure, retract the catheter until the proximal end of the coring element is aligned with the radiopaque marker on the sheath.Alternatively, if using the clottriever sheath, confirm the coring element location inside the sheath funnel when the proximal edge of the purple section of the outer catheter visibly exits the sheath.Ensure the element diameter is fully reduced by turning the handle knob toward the -" the device labeling includes the following warning statement: "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: 21699673
• Report Number: 3020347218-2025-00021
• Device Sequence Number: 15619128
• Product Code: QEW
• UDI-Device Identifier: 00850291007406
• UDI-Public: (01)00850291007406(17)261028(10)24100153
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 24100153
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLOTTRIEVER SHEATH, 16FR
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 95 KG