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

Model Number	51-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A 24-year-old male presented with left upper extremity swelling.His symptoms were consistent with thoracic outler syndrome and thrombus was identified extending from the brachial vein to just past the brachiocephalic vein.The plan was to gain brachial access and to use the 13 fr clottriever (ct) sheath.Access was gained and imaging was performed.The physician then decided to place the 13 fr ct sheath.The dilator was advanced into the vessel, but the patient expressed pain.Upon deployment of the funnel, the pain increased.Imaging was performed which revealed that the funnel was not deployed and the imaging appeared unusual.The decision was made to remove the sheath, but the physician experienced resistance.The physician pulled harder, and the sheath came out with vein encompassing the shaft.Extravasation was also discovered.Upon inspection, it was revealed that a 16 fr ct sheath was used instead of a 13 fr.Stasis was obtained and the patient was discharged later that day.It was reported that the patient returned to work the following morning but called the physician and complained of pain.Plans were made for the patient to undergo a rib resection.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.There was no report of any device malfunction.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari's chief medical officer, who concluded that the patient's injury was the result of user error (use in an undersized vessel).Vessel dissection and vessel perforation are listed in the device labeling as complications / adverse events.Manufacturer reference #: (b)(4).

• 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: 22080457
• Report Number: 3020347218-2025-00036
• Device Sequence Number: 18318558
• Product Code: QEW
• UDI-Device Identifier: 00850291007123
• UDI-Public: 00850291007123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 51-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; CLOTTRIEVER SHEATH, 13 FR
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male