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

Model Number	50-101
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts were made to obtain the device from the user facility, however, at this time it has not been returned.In the event the device is received for investigation a follow-up report will be sent.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.The company representative present during surgery examined the ct sheath after it was removed from the patient and described it as being very distorted and not straight as a result of manipulation during attempted removal.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 device insertion technique, resulting vessel perforation, and need for secondary surgical intervention were the result of use error.Vessel dissection and vessel perforation are listed in the device labeling as potential complications / adverse events.The device labeling includes the following warning: avoid using excessive force to advance or retract the clottriever sheath and dilator against resistance.If excessive resistance is encountered, remove the device.Excessive force against resistance may result in damage to the clottriever sheath and dilator and/or vessel.Manufacturer reference#: (b)(4).
Event or Problem Description
On (b)(6) 2023, a 55-year-old female hemodialysis patient underwent a thrombectomy for extensive clot in the left subclavian vein extending down the arm.The clot age was approximately 90 days.The physician dilated up to 14 fr and inserted a 13 fr clottriever (ct) sheath.Upon initial insertion of the first ct sheath, excessive manipulation resulted in a dent and damage to the dilator.A second ct sheath was opened and inserted.Upon insertion of this second sheath, the dilator became stuck in the patient.Various methods were employed to remove the dilator, including manual manipulation, oral administration of nitroglycerin, application of a tourniquet, and application of pressure to the armpit.Unfortunately, these efforts were unsuccessful and the patient was sent to the operating room for a venous cutdown.The ct sheath was embedded in the brachial vein, through a collateral, and had punctured the brachial artery.On march 30, 2023, inari received a user facility medwatch report#: (b)(4) from the fda via the medsun program.This report description was as follows: patient had left upper extremity dvt (deep vein thrombosis) with limited access due to hemodialysis.The 13 fr inari sheath was introduced via ultrasound guidance to access the left basilic vein.After the dilator was removed however the sheath was unable to be removed.This led to an operative procedure to remove the sheath.The original intended procedure was thrombectomy of left upper extremity deep vein thrombosis.

• Brand Name: CLOTTRIEVER 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 16694130
• Report Number: 3020347218-2023-00005
• Device Sequence Number: 15294312
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2023

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 Expiration Date: 03/11/2023
• Device Model Number: 50-101
• Device Lot Number: 21030024
• 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: 03/08/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2021
• 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: IVUS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American