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	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A 66-year-old female underwent a thrombectomy with the inari clottriever xl catheter (ctxl) to address her deep vein thrombosis (dvt).The patient had long-standing chronic clot.Two pulls were performed during which the ctxl removed only minimal clot.On the third pull, the ctxl became stuck at the iliac zone.The physician was unable to move the catheter, and during attempts to free it, the intri24 sheath came out of the patient's body.After 45-minutes, the physician decided to cut down the femoral vein.Despite the venous cutdown, the device was still stuck in the iliac so another cutdown was performed in the iliac region.The coring element had to be cut to manually extract the clot that was trapped within.The removed clot appeared chronic and was well organized.Additionally, blood was transfused to the patient during the procedure.There was damage to the external iliac vein and a tear at the end of the inferior vena cava into the iliac.Post-procedure follow up confirmed the patient is recovering and stable.In following up with the physician they indicated the ct xl effectively removed the thrombus from the ivc, though the size of the clot prevented complete removal.
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.There was no report of any device malfunction.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.The device instructions for use include the following warnings/contraindications: not indicated for the removal of fibrous, firmly adherent, or calcified material (e.G., atherosclerotic plaque).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 manufacturer reference #: (b)(4).

• 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: 20670038
• Report Number: 3020347218-2024-00046
• Device Sequence Number: 12572540
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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: 07/25/2026
• Device Model Number: 41-102
• Device Lot Number: 24070104
• 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: 10/14/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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: INTRI24 INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female