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

Model Number	41-102
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari's chief medical officer, who concluded that the patient's venous cutdown was the result of an overfilled collection bag.Manufacturer reference #: (b)(4).
Event or Problem Description
An individual with inferior vena cava (ivc) and external iliac deep vein thrombosis (dvt) underwent a thrombectomy with the clottriever xl catheter (ctxl).Intravascular ultrasound was performed to confirm the thrombus location and the size of the popliteal vein and ivc.There was a small clot in the external iliac, but the majority of the clot burden was in the infrarenal area of the ivc.The popliteal measured 10 mm which is the minimum size for usage of the ctxl and the ivc measured approximately 20 mm.During the first pass, the ctxl engaged clot but when the ctxl was brought into the sheath, the distal end of the catheter became stuck before entering the clottriever 16fr sheath.The physician attempted to remove it but was ultimately unsuccessful.The distal end was overfilled with clot and was too big to remove.The vascular team was called in and a cutdown was performed to remove the catheter from the body.The procedure unfortunately resulted in a small segment of vessel being damaged when the ctxl was retracted.A gore viabahn stent was sutured to the patients' popliteal vein.

• 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 ; 6513233614
• MDR Report Key: 20052407
• Report Number: 3020347218-2024-00039
• Device Sequence Number: 7955834
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223210
• 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): 08/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2026
• Device Model Number: 41-102
• Device Lot Number: 24020020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2024
• 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, 16 FR
• Outcome Attributed to Adverse Event: Disability; Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose