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

Model Number	50-101
Medical Device Problem Codes	Collapse (1099); Entrapment of Device (1212); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A female in her early 40s was diagnosed with a left upper extremity deep vein thrombosis (dvt).The clot age was approximately 20 days.The patient was scheduled to undergo a thrombectomy with the inari clottriever system.Access was attempted at the left basilic vein.The physician dilated and inserted the clottriever 13 fr sheath.At this point, it was assumed that the dilator became caught on a valve or narrow vein segment.After the funnel was deployed appropriately, the dilator became stuck in the vessel and was unable to be removed.Each attempt to retract the dilator crushed the funnel.The sheath was removed from the patient and additional dilation and ballooning of the access site was performed to remove the dilator; however, the basilic vein tore during device removal.The procedure was aborted and the patient was discharged the same day in stable condition.Additional information was requested from the physician who reported that the patient's veins are very resilient and the vein was expected to close off.
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.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 venous injury was the result of unintended user error where the device was subjected to excessive force.The patient's preexisting condition (paget-schroetter disease) can result in abnormal vasculature and is believed to be a contributing factor.The device instructions for use include the following warning statement, "avoid using excessive force to advance or retract the clottriever sheath and dilator against resistance.If excessive resistance is encountered, remove the device.Excessive force against resistance may result in damage to the clottriever sheath and dilator and/or vessel." vessel dissection and vessel perforation are listed in the device labeling as potential complications.Manufacturer reference #: (b)(4).

• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17822244
• Report Number: 3020347218-2023-00017
• Device Sequence Number: 6138203
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

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: 06/28/2025
• Device Model Number: 50-101
• Device Lot Number: 23060122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2023
• 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
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female