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

Model Number	50-101
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device identifiers were provided and the lot history records were reviewed.There were no discrepancies or unusual findings.A complaint history record review of this lot number revealed no similar complaints.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 foreign body removal was likely the result of user error where the sheath was inadvertently dissected and left in the patient.Manufacturer reference #: (b)(4).
Event or Problem Description
On october 9, 2023, a successful deep vein thrombosis (dvt) thrombectomy was performed using the inari clottriever system.On (b)(6) 2023, this patient underwent foreign body removal; imaging revealed that the foreign body originated from an inari clottriever sheath (distal 1 cm of the sheath and funnel).The material removed from the patient had a clean cut, likely from contact with a scalpel.The hospital is in current possession of the device fragment and is performing an internal analysis.
Additional Manufacturer Narrative
The original ct sheath 13 fr used during surgery was disposed of by the hospital and was not available for evaluation; however, the device fragment/foreign body removed from the patient was returned to the manufacturer and evaluated.The device fragment was identified as a sheath tip from the clottriever sheath.The sheath tip was removed from packaging, decontaminated, and photographed.Visual examination found that although the device fragment appeared to be a clean cut, further microscopic examination revealed fraying which indicates a material break.The hospital's internal investigation did not identify anything remarkable.The product issue will continue to be monitored for reoccurrence.The cause of the clottriever sheath tip fracture was most likely due to use error where excessive force was used to advance or retract the device against resistance.Other possible causes include patient anatomy and/or tortuous vasculature.The device labeling includes 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." 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18411122
• Report Number: 3020347218-2023-00030
• Device Sequence Number: 2932929
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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 Expiration Date: 05/18/2025
• Device Model Number: 50-101
• Device Lot Number: 23050073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: Required Intervention
• Patient Sex: Unknown