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

Model Number	44-101
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 an 82-year-old male underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The clot age was estimated at 28 days.After several successful passes completed using a revcore thrombectomy catheter (revcore), the physician completed one more pass to remove the last remaining clot.As the physician collapsed the coring element, it was noted on imaging that the tip did not move, and the medical team realized the tip had separated from the device.The catheter was removed, and the tip remained in the patient's vessel.Imaging showed 100% of the clot was removed from the patient's vessel.In the following days, the patient underwent a venous cutdown and the revcore tip was removed successfully.
Additional Manufacturer Narrative
The revcore thrombectomy catheter (revcore) catheter was returned to the manufacturer and evaluated.Visual inspection of the catheter confirmed the distal tip was separated from the catheter and no other signs of damage were observed.The tip was not returned as it was retained at the hospital after it was removed from the venous cutdown.The inner shaft was inspected under uv light for adhesive residue.As expected, adhesive residue was identified on the outer circumference of the shaft-tip junction.A sample of the residue was collected and analyzed using an ft-ir spectrometer and compared to an inventory unit that had undergone the lot release process and was deemed acceptable.The analysis found the composition and cure on the customer's unit were within acceptable limits.As the adhesive residue was deemed acceptable, and the tip was unable to be evaluated, the root cause of the issue was undetermined.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.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." "examine the revcore thrombectomy catheter prior to insertion to verify it is not damaged." 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618
• MDR Report Key: 20906960
• Report Number: 3020347218-2024-00051
• Device Sequence Number: 3969096
• Product Code: QEW
• UDI-Device Identifier: 00850291007383
• UDI-Public: 00850291007383
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2025
• Device Model Number: 44-101
• Device Lot Number: 23080025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLOWSAVER; PROTRIEVE SHEATH; TRIEVER16 CURVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 64 KG