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

Model Number	50-101
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clottriever sheath 13fr, was returned to the manufacturer and evaluated.The device was removed from the packaging, decontaminated, and photographed.Visual examination revealed that the clottriever sheath had a kink in the middle of the shaft.Aside from the kink in the sheath shaft the device met all dimensional specifications.No damage was observed on the funnel and the mesh was fully intact.The cause of the clottriever sheath shaft damage (kink) and getting stuck in the basilic vein was most likely due to excessive force used to advance/retract the device against resistance.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 vessel injury was likely the result of user error (use in undersized vein).Vessel dissection and vessel perforation are listed in the device labeling as potential complications / adverse events.The device labeling includes the following warning statement: avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel.Manufacturer reference #: (b)(4).
Event or Problem Description
A 65-year-old male patient with deep vein thrombosis (dvt) in the upper left extremity underwent a thrombectomy with the inari clottriever bold catheter.The clot age was estimated at 15 days.The treatment was successful with removal of the entire clot; however, when preparing for closure, the physician felt resistance as the clottriever sheath was being removed from the access site in the basilic vein.The physician applied excessive force to enable removal of the sheath and upon removal, it was noticed that the basilic vein had torn.A venogram was performed which revealed no harm to the deep venous system.The arm was wrapped with a compression bandage and the patient was transferred to the recovery room.The patient is expected to make a full recovery.

• 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: 18253159
• Report Number: 3020347218-2023-00023
• Device Sequence Number: 15230946
• 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): 12/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 50-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG