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	Foreign Body In Patient (2687)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient with deep vein thrombosis (dvt) and preexisting venous stents underwent thrombectomy with inari devices on (b)(6) 2024.The clot age was estimated at 180 days.During thrombectomy, flowtriever catheter, xl disks were placed above the patient's inferior vena cava (ivc) filter and intravascular ultrasound (ivus) was used to obtain measurements.After access was obtained, a revcore thrombectomy catheter (revcore) was advanced into the left popliteal vein.The revcore was used at the proximal edges of the stent and moved distally, using the scrubbing technique.No clot was removed after three passes.On the fourth pass, the physician moved the device inferior to superior, towards the confluence, and the medical team noticed the radiopaque tip was separated from the catheter and remaining on the guidewire, inferior to the stent.The medical team attempted to snare and aspirate the tip; however, the tip was irretrievable.The radiopaque tip remains in the patient, and a cook covered stent was placed on top of the tip.The case was concluded.There was no resulting patient injury or damage to the preexisting stents.Postoperatively, the patient is doing well in stable condition.
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 and visually inspected and photographs provided from the case were reviewed and no manufacturing deficiencies were identified.Additionally, no manufacturing deficiencies were observed during the adhesive residue test.A definitive root cause could not be established during the investigation; however, it was determined that the field failure may have been related to the device navigating a torturous 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 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: keith herbert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513236314
• MDR Report Key: 19262242
• Report Number: 3020347218-2024-00023
• Device Sequence Number: 2607919
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: 00850291007383
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 07/31/2025
• Device Model Number: 44-101
• Device Lot Number: 23070100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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 Sex: Male