MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13 FR; 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	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025 a 51-year-old female underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 365 days.After multiple passes, the funnel of the clottriever sheath, 13 fr (ct sheath) separated from the sheath shaft.The funnel was able to be removed with hemostats.There was no injury to the patient.
Additional Manufacturer Narrative
The clottriever sheath, 13 fr (ct sheath) was returned to the manufacturer and investigated.The ct sheath was returned with the distal end of the sheath separated from the rest of the sheath shaft.The pebax material at the fracture site was uneven and had signs of ductile strain.The liner within the sheath had delaminated from the pebax and the liner in the funnel side of the break had exhibited signs of being stretched.The sheath shaft was cross section and examined.The liner was found to have poor adhesion to the shaft.The cause of the break was likely due to liner delamination.The delamination of the liner caused the sheath shaft to be weaker.A crack or fracture is more likely in this condition if sheer force is applied.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.Manufacturer reference: (b)(4).

• Brand Name: CLOTTRIEVER SHEATH, 13 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 ; 6513233614
• MDR Report Key: 21755212
• Report Number: 3020347218-2025-00024
• Device Sequence Number: 12817255
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)260827(10)24080141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 08/27/2026
• Device Model Number: 50-101
• Device Lot Number: 24080141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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: CLOTTRIEVER BOLD CATHETER.; FLOWSAVER.; PROTRIEVE SHEATH.; REVCORE THROMBECTOMY CATHETER.; VENACORE CATHETER.
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG