MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH 16 FR.; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	51-101
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 56-year-old male underwent a thrombectomy using the inari clottriever system.While using flowstasis, the operator fully tightened the flowstasis before pulling the 16 fr.Clottriever sheath back.As it was pulled back, the sheath fractured.This left roughly 1 cm of the purple portion of the sheath and the entire funnel still inside the patient.A venous cutdown was performed successfully to remove the broken portion.The procedure continued and was completed successfully without any issues.
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.
Additional Manufacturer Narrative
The clottriever sheath, 16 fr was returned to the manufacturer and evaluated.The device was returned with the distal section of the shaft separated from the rest of the sheath.A visual inspection was performed which showed that the proximal side of the fracture contained the remainder of the liner from the distal section, and the coil was damaged.The proximal part of the shaft also had a small hole in the pebax near the fracture site.The liner was a clear color with small indents at the distal end, indicating that the liner was adhered to the funnel prior to the fracture.The distal piece of the shaft that had separated contained a hole in the pebax and an unknown object sticking out of the hole.An unknown foreign object could also be observed stuck inside the funnel.The object was extracted from the funnel and found to be a third-party balloon-like device.The third-party device was also identified as the object poking through the hole in the pebax.The length of the distal piece of pebax was measured close to the cut length indicating the fracture happened close to the fuse joint.The distal piece of pebax did not include any ptfe liner.Poor liner adhesion to the pebax can cause the liner to fold over and result in weak areas of the pebax.Because the fuse joint is already a potential weak point, it is reasonable to conclude that poor pebax lamination or fusing process could contribute to a fracture of the shaft at this point.However, it is also likely that excessive forces during handling contributed to the fracture, as even with poor liner fusion to the pebax, a significant amount of force would be required to break the pebax and coil.The discovery of a third-party device inside the sheath funnel complicates the root cause determination, because the device was likely used off-indication with an incompatible device.The use of the third-party device therefore could have increased the forces applied to the sheath and resulted in damage that would not have occurred if compatible inari devices were used instead.

• Brand Name: CLOTTRIEVER SHEATH 16 FR.
• 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 ; 9294132147
• MDR Report Key: 21638930
• Report Number: 3020347218-2025-00018
• Device Sequence Number: 17849635
• Product Code: QEW
• UDI-Device Identifier: 00850291007123
• UDI-Public: (01)00850291007123(17)260911(10)24090041
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2026
• Device Model Number: 51-101
• Device Lot Number: 24090041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLOWSTASIS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male