MAUDE Adverse Event Report: Inari Medical, Inc. ClotTriever Sheath, 13Fr, 15cm; Peripheral Mechanical Thrombectomy With Aspiration

Model Number	50-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(949)413-2147
• MDR Report Key: 50439779
• Report Number: 3020347218-2026-00063
• Device Sequence Number: 8827392
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)280213(10)26020092
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 08/25/2026

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: 50-101
• Device Catalogue Number: 50-101
• Device Lot Number: 26020092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2026
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 200 LB