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

Model Number	25-101
Medical Device Problem Codes	Retraction Problem (1536); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
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 reference: (b)(6).
Event or Problem Description
On (b)(6) 2025, a 35-year-old female underwent deep vein thrombosis (dvt) thrombectomy using inari devices.Upon removal of the triever16 (t16), during the thrombectomy, some resistance was felt.The t16 broke in half with the two halves connected by the inner coil.The device was able to be fully removed from the patient without issue and there was no injury to the patient.A new device was opened and the thrombectomy was completed without further issue.
Additional Manufacturer Narrative
The treiver16 (t16) was returned to the manufacturer and evaluated.Visual inspection of the device revealed a complete separation of the t16 shaft at approximately 15.5 inches from the distal end of the catheter.The 35d pebax outer layer and ptfe liner were fully sheared, resulting in disconnection between the proximal and distal segments.The stainless-steel coil remained intact.The separation was likely the result of excessive manipulation during use and excessive force used against resistance, likely exasperated by anatomical challenges.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted and no similar issues have been reported against this lot number.The device labeling includes the following warning statement: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation" manufacturer reference: (b)(4).

• Brand Name: TRIEVER16
• 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 ; 6513233614
• MDR Report Key: 22177174
• Report Number: 3020347218-2025-00038
• Device Sequence Number: 9263314
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: (01)00850291007130(17)250822(10)23080068
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 Expiration Date: 08/22/2025
• Device Model Number: 25-101
• Device Lot Number: 23080068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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: CLOTTRIEVER SHEATH, 16FR; FLOWSAVER; VENACORE CATHETER
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 68 KG