MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER24, 24FR, 90CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	22-101
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	10/28/2025
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 not provided, the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.The case was reviewed by inari stryker medical affairs, who concluded that the patient¿s injury was likely the result of inadvertent catheter perforation.The device labeling lists perforation of pulmonary arteries, and vessel dissection/perforation as possible complications/adverse events.Manufacturer reference number (b)(4).
Event or Problem Description
On (b)(6) 2025, a 75-year-old male underwent pulmonary embolism (pe) thrombectomy.The patient had spine surgery two days before the thrombectomy and the patient was scheduled to have a mass removed the day following the thrombectomy.After accessing the right side, the medical team had trouble keeping the wire placement on the right side as the patient's pulmonary arteries were enlarged.The triever24 catheter (t24) flipped when the dilator was removed before the first right side aspirations.The catheter was adjusted to the correct placement and the procedure continued.Before the third aspiration, the catheter was advanced with the tip of the guidewire outside of the catheter.The patient's pressures started to drop, and the patient was administered vasopressors.The patient was then intubated and a code blue was called.The patient had his chest cracked and a small perforation was noted.The patient was eventually stabilized and was later discharged home.

• Brand Name: TRIEVER24, 24FR, 90CM
• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 23647159
• Report Number: 3020347218-2025-00084
• Device Sequence Number: 13235704
• Product Code: QEW
• UDI-Device Identifier: 00850291007185
• UDI-Public: 00850291007185
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 22-101
• Device Catalogue Number: 22-101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male