MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 13 FR; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	50-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari device was discarded by the user facility and are not available for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.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 vessel injury was likely the result of user error (use in an undersized vein).Vessel dissection and vessel perforation are listed in the device labeling as complications / adverse events.Manufacturer reference #: (b)(4).
Event or Problem Description
A 53-year-old female with a history of stage 4 breast cancer and ongoing gastrointestinal (gi) illness presented to the emergency department with exertional dyspnea.The patient was admitted to the hospital and during her stay the patient developed right upper extremity swelling unresolved by the lymphedema pump.A duplex ultrasound was performed which revealed deep vein thrombosis (dvt) in the upper right extremity.A thrombectomy was scheduled with the inari clottriever system.During the thrombectomy, the patient's right brachial vein was utilized as the access site.The procedure was successful, and the complete thrombus was removed.The post-procedure venogram and intravascular ultrasound revealed restored patency.However, upon removal of the clottriever sheath 13 fr, a small segment of the patient's brachial vein avulsed outside the arm.The physician tied down the vein and surgically sutured it to control bleeding.Minimal blood loss was noted and no other complications occurred.Additional information has been requested from the physician.

• 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18323429
• Report Number: 3020347218-2023-00026
• Device Sequence Number: 12521358
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221531
• 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): 12/13/2023

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: 50-101
• 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: Not provided
• Initial Report FDA Received Date: 12/13/2023
• 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: CT BOLD CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female