MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER SHEATH, 16FR, 15CM; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	51-101
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Upon completion of the investigation, a follow-up report will be submitted.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 58-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient underwent a pulmonary embolism (pe) thrombectomy two days prior.During the dvt thrombectomy, the patient was positioned frog legged and resistance was felt performing the micropuncture due to chronic clot.As the clottriever sheath, 16 fr (ct sheath) advanced, it became stuck.When the ct sheath was pulled back, the funnel separated from the device.The funnel was successfully removed throughvenous cutdown.
Additional Manufacturer Narrative
Manufacturer reference number: (b)(4).The suspect device was returned and evaluated.Visual examination found that the clottriever sheath funnel was separated from the sheath body.The cause of the clottriever sheath funnel separation was most likely due to excessive force used to advance/retract the device against resistance.Excessive force can cause damage to the sheath.Additionally patient anatomy and/or a tortuous insertion pathway can contribute to sheath damage.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted, and no similar issues have been reported against this lot number.The device labeling includes vessel damage as a possible adverse event/complication.The stryker peripheral vascular medial affairs team determined the clottriever sheath may have caused or contributed to the patient's vessel damage.
Event or Problem Description
On (b)(6) 2025, a 58-year-old male patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient underwent a pulmonary embolism (pe) thrombectomy two days prior.During the dvt thrombectomy, the patient was positioned frog legged and resistance was felt performing the micropuncture due to chronic clot.As the clottriever sheath, 16 fr (ct sheath) advanced, it became stuck.When the ct sheath was pulled back, the funnel separated from the device.The funnel was successfully removed throughvenous cutdown.

• Brand Name: CLOTTRIEVER SHEATH, 16FR, 15CM
• 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 9494132147
• MDR Report Key: 24075270
• Report Number: 3020347218-2026-00002
• Device Sequence Number: 18708786
• Product Code: QEW
• UDI-Device Identifier: 00850291007123
• UDI-Public: (01)00850291007123(17)270620(10)25060114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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 Model Number: 51-101
• Device Catalogue Number: 51-101
• Device Lot Number: 25060114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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 Age: 58 YR
• Patient Sex: Male