MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI CLOTTRIEVER SHEATH; EMBOLECTOMY CATHETER

Model Number	50-101
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari device was discarded by the user facility and is not available for evaluation.The device identifiers were provided and the lot history records 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 event was reviewed by inari's chief medical officer, who concluded that the vessel injury was caused by removal of the clottriever sheath.It should be noted that the device labeling includes the following instructions: pre-dilate the access site by advancing a 16 fr or 18 fr dilator, for the 13 fr and 16 fr sheath systems, respectively, over the 0.035" guidewire and into the access site.Vessel dissection is listed in the device labeling as a potential complication / adverse event.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6)-year-old female patient presented to the hospital with upper extremity deep vein thrombosis (dvt) extending from the proximal basilic vein to the subclavian.On (b)(6) 2021, the inari medical clottriever (ct) was used to attempt to treat the dvt.After ultrasound-guided access was obtained, a cook medical bentson wire guide was advanced before being exchanged for a boston scientific amplatz super stiff guidewire.A phillips visions pv.035 digital ivus catheter was then used to confirm clot location and vessel size.The vessel was dilated with a 14f coons dilator, the ct sheath was inserted over the guidewire, and the ct dilator was advanced.After dilation, the physician began to withdraw the ct dilator and encountered substantial resistance.The physician paused removal to make a small incision in the vein before continuing.While attempting to remove the devices, it was noted that the vein wall was being stripped.After the devices were removed, the physician ligated the vein, and the procedure was concluded.The physician noted that engaging the ct dilator tabs during withdrawal may have caused the device to catch the vein wall, pulling it down and catching it in the sheath funnel.

• Brand Name: INARI CLOTTRIEVER SHEATH
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• MDR Report Key: 12047018
• Report Number: 3011525976-2021-00015
• Device Sequence Number: 4424000
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 01/13/2023
• Device Model Number: 50-101
• Device Lot Number: 21010014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 14F COONS DILATOR; AMPLATZ SUPER STIFF GUIDEWIRE; COOK MEDICAL BENTSON WIRE GUIDE; PV .035 DIGITAL IVUS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 28 YR