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

Model Number	42-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An 84-year-old female underwent a thrombectomy using the inari clottriever bold system to address her upper extremity deep vein thrombosis.After wire positioning was obtained, the 13 fr clottriever sheath was placed and the clottriever bold catheter was advanced into place.A pass was performed which removed chronic clot.An angiogram was performed and extravasation was discovered near the funnel.An angioplasty was performed by ballooning.After 20 minutes, the physician was satisfied that the vessel did not need further treatment or stenting.The physician also identified a pseudo aneurysm; however, no additional treatment was necessary.The case was completed successfully.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, the lot history records of all potential lots shipped to the facility 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 potentially the result of inadvertent vascular dissection.Vessel dissection and vessel perforation are listed in the device labeling as potential complications/adverse events.Manufacturer reference #: (b)(4).

• Brand Name: CLOTTRIEVER BOLD 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: 22056636
• Report Number: 3020347218-2025-00031
• Device Sequence Number: 20622316
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230494
• 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): 05/20/2025

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 Model Number: 42-102
• 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: 04/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female