MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16, 16FR, 107CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer's reference number (b)(4).
Event or Problem Description
On (b)(6) 2026 a patient underwent pulmonary embolism (pe) thrombectomy using stryker peripheral vascular devices.While removing the triever16, a section of the catheter that was already outside of the patient's vasculature broke in half.The distal end was able to be removed from the patient without issue.
Event or Problem Description
On (b)(6) 2026, a patient underwent pulmonary embolism (pe) thrombectomy using stryker peripheral vascular devices.While removing the triever16, a section of the catheter that was already outside of the patient's vasculature broke in half.The distal end was able to be removed from the patient without issue.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The suspect device was returned to the manufacturer and evaluated.The assigned root cause of the funnel damage is excessive forces applied to the device during handling.The break in the catheter is consistent with force applied to the catheter during use.Per device labelling, "avoid using excessive force to advance or retract against resistance.Excessive force against resistance may result in damage to the device or vessel perforation,".Although the lot number was not provided, lots were pulled from shipping records and were used to conduct the product and lot history review.There were no discrepancies or unusual findings and no notable trends have been reported against the possible lot numbers.Although there was no patient harm the information available reasonably suggest that the device has malfunctioned and that if this malfunction were to recur, it may cause or contribute to a death or serious injury.

• Brand Name: TRIEVER16, 16FR, 107CM
• 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: 24678050
• Report Number: 3020347218-2026-00027
• Device Sequence Number: 10360473
• Product Code: QEW
• UDI-Device Identifier: 00850291007437
• UDI-Public: 00850291007437
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223419
• 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,Followup
• Report Date (Section B): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25-101
• Device Catalogue Number: 25-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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
• Patient Sex: Unknown