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); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/11/2025
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.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 injury was the result of inadvertent catheter dissection.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." the device labeling includes the following contraindications: "not intended for use in vessels < 10 mm." vessel dissection is listed as a possible adverse event/complication.Manufacturer reference #: (b)(4).
Event or Problem Description
A 76-year-old female presented to the emergency room with left leg swelling and pain.An ultrasound was performed which revealed clot extending from the common femoral vein down to the popliteal vein.A thrombectomy was performed with the inari clottriever (ct) system.The patient was placed prone, and access was obtained using ultrasound.Wire positioning was achieved, and the 13 fr clottriever sheath was inserted in the popliteal vein.A ct catheter was used to perform 8 passes which yielded acute clot.Imaging was performed after this which revealed a duplicate femoral vein system and clot in an aneurysmal segment in the proximal iliac.A ct bold was then used to perform 2 passes which yielded a small amount of clot.Another venogram was performed which showed clots remaining in the aneurysmal segment in the proximal iliac.The sheath was exchanged for a 16 fr ct sheath and a ctxl was inserted.Resistance was noted when the tip of the ctxl was at the confluence of the inferior vena cava.The decision was made to remove ctxl undeployed, but resistance was again noted during removal.A venogram was performed which revealed extravasation in the duplicate femoral vein.A 7 mm viabahn stent was placed at the point of extravasation and the final venogram showed no signs of extravasation with brisk outflow noted.

• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9294132147
• MDR Report Key: 21590200
• Report Number: 3020347218-2025-00017
• Device Sequence Number: 20899552
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: (01)00850291007277(17)260928(10)24090128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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: 09/29/2026
• Device Model Number: 41-102
• Device Lot Number: 24090128
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: 13 FR CLOTTRIEVER SHEATH.; 16 FR CLOTTRIEVER SHEATH.; CLOTTRIEVER BOLD CATHETER.; CLOTTRIEVER CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Female