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

Model Number	53-101
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, the lot history records of all potential lots shipped to the facility were reviewed.There were no discrepancies or unusual findings.There was no report of any device malfunction.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 stryker medical affairs, who concluded that the patient's injury was the result of user error.Vessel or graft dissection is listed as a possible adverse event/complication.The device labeling cautions, "ensure that inthrill thrombectomy catheter is withdrawn into the inthrill sheath prior to removal from patient to avoid vascular damage." manufacturer reference #: (b)(4).
Event or Problem Description
A patient underwent a thrombectomy to address their left upper extremity deep vein thrombosis with the inthrill thrombectomy catheter.After multiple passes were performed, the physician began to remove the sheath to flush.However, the sheath was pulled without re-sheathing the funnel which resulted in the brachial vein being pulled out of the access site.The vein was ligated and the final venogram was performed which showed full patency.

• Brand Name: INTHRILL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; irvine, CA 92618 ; 9493744235
• MDR Report Key: 22734123
• Report Number: 3020347218-2025-00049
• Device Sequence Number: 8419036
• Product Code: DYB
• UDI-Device Identifier: 00850291007369
• UDI-Public: 00850291007369
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K250421
• 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): 08/06/2025

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 Model Number: 53-101
• 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: 07/08/2025
• Initial Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: INTHRILL THROMBECTOMY CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown