MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13FR, 15CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	50-101
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
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 reference number: (b)(4).
Event or Problem Description
On (b)(6) 2026, a patient underwent thrombectomy using the clottriever system of devices.During the procedure, a clottriever sheath hemostasis valve separated from the rest of the catheter.Additional product was used to complete the procedure and the patient did not experience any adverse events or injury as a result.
Event or Problem Description
On (b)(6) 2026, a patient underwent thrombectomy using the clottriever system of devices.During the procedure, a clottriever sheath hemostasis valve separated from the rest of the catheter.Additional product was used to complete the procedure and the patient did not experience any adverse events or injury as a result.
Additional Manufacturer Narrative
The suspect device was returned to the manufacturer and evaluated.The reported complaint is confirmed.The catheter shaft was separated from the swivel hub.A capa was initiated to further investigate this complaint and document corrective actions taken to address the failure mode.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.There was no patient harm; however, the information 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.The device labeling includes vessel damage as a possible adverse event/complication.Manufacturer reference number: (b)(4).

• Brand Name: CLOTTRIEVER SHEATH, 13FR, 15CM
• 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: 24508355
• Report Number: 3020347218-2026-00018
• Device Sequence Number: 9870233
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)260816(10)24080079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K233815
• 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 Expiration Date: 08/16/2026
• Device Model Number: 50-101
• Device Catalogue Number: 50-101
• Device Lot Number: 24080079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG