MAUDE Adverse Event Report: INARI MEDICAL, INC. VENACORE 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	05/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer and evaluated.Both the tip and catheter were returned.Visual inspection confirmed there was a glue filet present, in the correct location, proximal to the tip.A deformation was also noted on the distal tip.The groove in the deformation was measured to be.005" across.No defects were observed on the delivery catheter.The tip was cut axially down the length to inspect the adhesive deposition.Using a black light, glue was determined to be present on the correct bond location within the tip as well as the surface of the inner catheter.Backloading the device and breaking though the occlusion with the backend of the guidewire likely caused the tip to become compromised and ultimately separate from the delivery catheter.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: "examine the venacore thrombectomy catheter prior to insertion to verify it is not damaged." "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).
Event or Problem Description
A male patient with deep vein thrombosis (dvt) underwent dvt thrombectomy using inari devices on (b)(6) 2024.He had a history of dvt in 2023.The clot age was estimated at 175 days.Prior to thrombectomy, the physician attempted to load the device onto the guidewire but noticed the lumen was blocked approximately 1mm into the lumen.As an attempt to troubleshoot, the physician flipped the device and inserted the stiff proximal end of the amplatz super stiff guidewire through the proximal end of the venacore.It was advanced to the distal tip where resistance was felt again, though the physician was able to break through with force.The procedure continued uneventfully using the venacore device and after the eighth pass, the physician over-sheathed the tip using the delivery catheter.No resistance was felt as the physician continued to push forward beyond where the tip is anchored.The tip was pushed distally by the delivery catheter as it detached from the inner shaft.The venacore catheter was removed from the patient while the tip remained on the treatment guidewire, in the patient's body.The physician was able to remove the tip by snaring it on the treatment guidewire and removed both the tip and guidewire together.The case was concluded.Approximately 30% of clot was removed.There was no resulting patient injury, and the patient was in stable condition after the procedure.

• Brand Name: VENACORE 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: 19585867
• Report Number: 3020347218-2024-00028
• Device Sequence Number: 14281640
• Product Code: QEW
• UDI-Device Identifier: 00850291007406
• UDI-Public: 00850291007406
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 09/11/2024
• Device Model Number: 46-101
• Device Lot Number: 24030032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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: AMPLATZ SUPER STIFF WIRE; CLOTTRIEVER SHEATH, 13 FR
• Patient Sex: Male