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	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 50-year-old male patient with a lower-left extremity (lle) deep vein thrombosis (dvt) and preexisting venous stent underwent thrombectomy with inari devices on (b)(6), 2024.The clot age was estimated at 21 days.During thrombectomy, the patient was positioned supine and the clottriever sheath, 13fr (ct sheath) was inserted into the left popliteal vein and the protrieve sheath (pt sheath) was placed in the right internal jugular vein.The revcore catheter was advanced through the ct sheath in the popliteal vein and completed two successful passes central to peripheral, with the coring element opened less than half full size.While repositioning for a third pass, the medical team noticed the revcore catheter radiopaque tip and coring element had separated as the radiopaque tip was observed at the central end of the implanted stent and the coring element was observed at the peripheral end of the stent.The physician then advanced the guidewire through and external to the pt sheath until the radiopaque tip was safely removed from the patient.The remainder of the revcore catheter was safely removed though the original point of access, via the ct sheath in the left popliteal vein.The case completed after five additional successful passes using a clottriever and clottreiver bold catheter.There was no resulting patient injury and the stent did not dislodge or become damaged.An estimated 99% of the clot was removed with significant improvement in flow.
Additional Manufacturer Narrative
The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The device has been returned to the manufacturer for evaluation.Upon completion of the investigation a follow-up report will be submitted.There have been no similar complaint events for this lot number.The device labeling includes the following warning statement: "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.".Stent entanglement is identified in the device labeling as a potential complication.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) was returned to the manufacturer and evaluated.The catheter was returned without the tip.No manufacturing deficiencies were identified when the catheter was visually inspected nor when photographs of the issue from the case were reviewed.Adequate adhesive residue was observed in the correct location.The root cause was not established during the investigation; however, the field failure was most likely due to the device navigating a tortuous anatomy.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.There have been no similar complaint events for this lot number.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 92816
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92816
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92816 ; 6513233614
• MDR Report Key: 19169611
• Report Number: 3020347218-2024-00021
• Device Sequence Number: 17974503
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: 00850291007383
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 08/17/2025
• Device Model Number: 44-101
• Device Lot Number: 23080062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 205 KG