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

Model Number	41-102
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clottriever xl catheter (ct xl) was returned to the manufacturer and evaluated.The device was received with the collection bag and coring element partially deployed and the plunger in the closed position.Visual inspection revealed the delivery catheter was dented and damaged near the distal tip and the middle catheter was kinked between the catheter hub and the handle.Resistance was felt at the area that corresponded with the dent damage on the delivery catheter when an attempt was made to retract the coring element and bag into the delivery catheter.The coring element then became stuck a few inches into the delivery catheter.The ct xl became stuck in the sheath during the procedure and was unable to be retracted into the delivery catheter likely due to the dent damage on the delivery catheter.The damage decreased the inner diameter of the delivery catheter which then required excessive force to be used to retract the coring element.The damage to the delivery catheter was likely caused by excessive force used during the procedure.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 warning statements: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and 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 clottriever xl catheter prior to insertion to verify it is not damaged." "ensure that clottriever xl catheter is withdrawn into the clottriever thrombectomy system sheaths prior to removal from patient to avoid vascular damage." manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2024, a 65-year-old male underwent a deep vein thrombosis (dvt) thrombectomy using inari devices.The clot age was estimated at seven days.During the thrombectomy, after the fifth pass using a clottriever xl catheter (ct xl), the catheter became stuck in the sheath while attempting to remove the ct xl catheter from the patient.The physician was able to remove the ct xl and the sheath together without injury to the patient.Once the devices were removed from the patient, the ct xl was able to be removed from the sheath, however the coring element and basket were then unable to be resheathed into the ct xl delivery catheter.A clottriever bold catheter was used to complete the case without further issues, and it was estimated that 100% of the clot was removed from the patient.

• Brand Name: CLOTTRIEVER XL 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: 20785507
• Report Number: 3020347218-2024-00047
• Device Sequence Number: 8942896
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K242557
• 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): 11/26/2024

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: 04/17/2026
• Device Model Number: 41-102
• Device Lot Number: 24040082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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, 13 FR; CLOTTRIEVER SHEATH, 16FR
• Patient Age: 65 YR
• Patient Sex: Male