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

Model Number	60-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inari devices were retained at the hospital per policy, are not available for evaluation.The inari account manager was interviewed and stated the dilator split in half along the guidewire.The patient had a lot of scar tissue in the access site (jugular).The patient did not experience any injury due to the dilator splitting.A new sheath was opened, and the case was completed without further issues.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).
Event or Problem Description
On july 15, 2025, inari medical received a copy of a voluntary medwatch mw5172147 that stated a protrieve sheath tore apart on insertion into the insertion port and it did not enter the patient.The device was no longer used during the procedure.Per medwatch event/problem section "inari sheath, on insertion, tore apart, md discontinued use of the product.The device did not enter the pt just the insertion port.".

• Brand Name: PROTRIEVE SHEATH
• 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 ; 8779234747
• MDR Report Key: 22799034
• Report Number: 3020347218-2025-00051
• Device Sequence Number: 18340266
• Product Code: QEW
• UDI-Device Identifier: 00850291007222
• UDI-Public: (01)00850291007222(17)260515(10)24050054
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K230331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 05/15/2026
• Device Model Number: 60-101
• Device Lot Number: 24050054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White