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

Model Number	50-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari device was discarded by the user facility and is therefore not available for analysis.The device history records for this manufacturing lot were reviewed and there were no anomalies, discrepancies, or non-conformances.There was no report of a device malfunction.This event is related to a prior complaint event; however, there was no patient injury reported.The initial information noted by the company representative in attendance was that they were "uncertain that we were in the correct vessel.Could not get funnel to open and once open, we couldn't advance the catheter past the common femoral vein." note: the inari device (funnel) is designed to prevent opening in a situation where the vessel is not large enough to accommodate the funnel.Based on the social media photograph it was estimated that the vein outer diameter was 1.9 mm, which is well below the recommended minimum vessel inner diameter of 6 mm, as stated in the device instructions for use.The labeling includes the following contraindication: "not intended for use in vessels < 6 mm".The root cause analysis performed by inari concluded that it is likely the clottriever sheath was accidentally placed in the smaller saphenous vein, rather than the appropriately sized popliteal vein.The vein was too small for the device and was stripped from the patient upon during removal of the sheath removal.Vessel perforation is listed in the device labeling as a potential complication associated with thrombectomy/embolectomy procedures.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(4) 2019, inari became aware via social media of an adverse event involving the inari clottriever thrombectomy system which was being used during a peripheral thrombectomy treatment.The posting described an event that occurred on (b)(6) 2019 where a portion of the patient's right saphenous vein was inadvertently extracted.Follow-up information was requested from the company representative who attended the case.After placement of the clottriever sheath, the clottriever catheter was inserted into what was thought to be the femoral vein, but it would not pass the common femoral area.The clottriever catheter was withdrawn, then two attempts were made to dilate the area with a 10 mm balloon.After each dilation attempt, the physician tried to re-advance the clottriever catheter, but was still unable to pass the common femoral area.Venography of the area showed no contrast flow past this area, leading to the conclusion that collateral veins had formed.The vascular surgeon therefore elected to abort the thrombectomy procedure and noted resistance while removing the clottriever sheath.Upon removal from the patient, the physician noted that he had removed an approximate 15 cm segment of saphenous vein.Pressure was applied and the vein was closed without the need for sutures.The patient was reported as doing fine.

• Brand Name: CLOTTRIEVER SHEATH
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• MDR Report Key: 8886320
• Report Number: 3011525976-2019-00003
• Device Sequence Number: 2119742
• Product Code: DXE
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2019

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: 05/01/2021
• Device Model Number: 50-101
• Device Lot Number: 19050001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 66 YR
• Patient Weight: 113