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

Model Number	21-101
Medical Device Problem Codes	Retraction Problem (1536); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 56-year-old female with deep vein thrombosis (dvt) underwent a thrombectomy in the left leg with the inari flowtriever system on (b)(6) 2023.The patient also had an inferior vena cava (ivc) filter placed 90 days prior.The triever20 (t20) was deployed and 5 aspirations were performed in the left leg with approximately 225 cc of blood returned via the inari flowsaver device to the right leg (popliteal access).A penumbra indigo system cat 8 device was then used to clear collateral thrombus.The t20 was re-inserted to clear thrombus from the femoral-popliteal, common femoral, and external iliac veins.However, the t20 became caught in the vessel.The surgeon made various attempts to remove the t20, including use of vasodilators, lubricants, and ballooning, but the t20 was unable to be removed.Before the second ballooning attempt, the t20 sheared at the popliteal access.Eventually, cardiothoracic surgery intervened to perform a venous cutdown on the common femoral vein and the t20 was removed.The thrombectomy was successful in removing 90% of the clot burden and the patient made a full recovery.
Additional Manufacturer Narrative
The triever20 was returned to the manufacturer and evaluated.The device was subjected to microscopic visual inspection.Dissection of the catheter revealed that the site of separation appeared to be at the braid/coil intersection.Aside from the separation, the liner appeared intact and there were no exposed coils or other findings and the device met dimensional specifications.The catheter separated outside of the patient's body likely due to excessive force pulling on the catheter during attempts to remove it from the vessel.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.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 investigation revealed no definitive root cause as to why the catheter became caught in the vessel.However, the case was reviewed by inari's chief medical officer, who concluded that the patient's venous cutdown was most likely the result of vasospasm and may have been used in an undersized vessel.The device labeling includes the following warning statement, "avoid using excessive force to advance or retract the flowtriever catheter or triever20 against resistance.If excessive resistance occurs, retract and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." manufacturer reference #: (b)(4).

• Brand Name: FLOWTRIEVER CATHETER
• 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: 16568390
• Report Number: 3020347218-2023-00003
• Device Sequence Number: 17498533
• Product Code: QEW
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213402
• 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): 03/17/2023

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: 12/02/2024
• Device Model Number: 21-101
• Device Lot Number: 22110004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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: INARI FLOWSAVER.; PENUMBRA INDIGO SYSTEM CAT 8.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 77 KG