MAUDE Adverse Event Report: INARI MEDICAL, INC. INTRI24 SHEATH; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	52-101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inari intri24 sheath was returned to the manufacturer and is pending evaluation.The device identifiers were provided and the lot history records were reviewed.There were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Event or Problem Description
An 81-year-old male underwent a thrombectomy on (b)(6) 2023 to address bilateral pulmonary embolism (pe).The clot age was estimated at 7 days.During the case, the inari intri24 introducer sheath was inserted into the patient over an amplatz guidewire.Upon insertion, the intri24 dilator broke within the patient's vasculature.The broken device fragment was successfully retrieved using an angioplasty balloon.There was no resulting injury to the patient.Another device was opened, and the procedure was completed successfully without further issues.The thrombectomy removed 95% of the pe.
Additional Manufacturer Narrative
The intri24 introducer sheath was returned to the manufacturer.The device was unboxed, decontaminated, and photographed.The dilator tip was confirmed to be broken off.The device was examined microscopically, and a capa was initiated in response to this complaint.Attempts were made to replicate the device breakage by bending the tip 90 degrees at the taper transition.The bend tests that were performed were subjected to greater force than what the dilators typically encounter during clinical use.However, the bend tests performed did not show any signs of breakage or signs of fatigue/material damage.Aspects of the dilator manufacturing process were modified to further attempt to replicate the failure through 90 degree bend testing.These modifications included: 10 intri24 dilators were placed in the freezer for 72 hours; 1 intri24 dilator was processed with no pre-taper; 1 intri24 dilator was processed through the rf cycle 5 times; 3 intri24 dilators were subjected to 600 degree f for 30 seconds at the tip; intri24 dilators were subject to >100 psi air pressure.No tip failures occurred in any of these modifications.The original dilator sample which experienced the breakage was sent to the supplier for analysis as well.The inspection found no signs of process-related failures or voids in the plastic material.Comprehensive failure analysis revealed no definitive root cause.There have been no similar complaint events of this nature with the intri24 sheath.Manufacturer reference #: (b)(4).
Event or Problem Description
Additional event information was requested and it was clarified that there was no unusual resistance or force experienced when inserting the dilator.Insertion was monitored via fluoroscopy; when the dilator reached the femoral head it appeared as though the dilator was no longer moving as a single unit.

• Brand Name: INTRI24 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 17892509
• Report Number: 3020347218-2023-00018
• Device Sequence Number: 7389814
• Product Code: QEW
• UDI-Device Identifier: 00850291007260
• UDI-Public: 00850291007260
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K212392
• 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): 04/02/2024

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: 05/17/2025
• Device Model Number: 52-101
• Device Lot Number: 23050061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 10/07/2023
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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: AMPLATZ GUIDEWIRE
• Patient Age: 81 YR
• Patient Sex: Male