MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16; INTRODUCER CATHETER

Model Number	25-101
Medical Device Problem Codes	Break (1069); Collapse (1099); Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inari device was returned to inari for evaluation and the findings will be summarized in a supplemental report.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Manufacturer reference #: (b)(4).
Event or Problem Description
A female patient in her early 40s was diagnosed with a chronic deep vein thrombosis (dvt) in the left leg.On (b)(6) 2022, the patient underwent a thrombectomy with the inari flowtriever retrieval/aspiration system.While utilizing the triever16 (t16) in the left popliteal vein, a portion of the t16 broke off into the deep femoral vein.At this point, approximately 10% of the clot had been retrieved.The physician was able to advance a kelly forceps a few centimeters into the access track and successfully remove the broken piece.There was no resulting patient harm.The treating physician suspected the patient had scar tissue that caught on the t16 catheter.The company representative present during the case clarified that the procedure was completed uneventfully using balloon dilation to address the scar tissue in the vessel.
Additional Manufacturer Narrative
The triever16 was returned to the manufacturer and evaluated.The device was subjected to dimensional evaluation and visual inspection.The dimensional analysis demonstrated that the luer and dilator met dimensional specifications.Visual inspection confirmed the break and identified obvious damage in two other locations; leading up to the shaft break, approximately 29 cm from the distal tip of the shaft, the shaft was crushed and compromised.Additionally, after the shaft broke in the braided section, the shaft was crushed and compromised.Both damaged locations indicate the device was subjected to excessive force/manipulation.In addition, a slight deformation was observed on the dilator; the etiology of this finding remains unknown.The root cause analysis concluded the catheter breakage was most likely attributed to inadvertent use error (device manipulation and no introducer sheath used) combined with patient anatomy (scar tissue present in treatment area); the slight deformation observed on the dilator may also have contributed.The device labeling includes the following warning statement: "do not advance catheter without dilator fully inserted.Avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and remove the device.Excessive force against resistance or advancement without dilator fully inserted may result in damage to the device or vessel perforation".Manufacturer reference #: (b)(4).

• Brand Name: TRIEVER16
• Common Device Name: INTRODUCER CATHETER
• 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: 15602183
• Report Number: 3020347218-2022-00003
• Device Sequence Number: 2200807
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: 00850291007130
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2024
• Device Model Number: 25-101
• Device Lot Number: 22040071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: FLOWSAVER
• Patient Age: 42 YR
• Patient Sex: Female