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

Model Number	50-101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b(6), 2025 a male patient underwent a deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 10 days old.During the thrombectomy, the patient was positioned frog-legged.A clottriever sheath, 13 fr (ct sheath) was used to insert the devices.During the procedure, the sheath shaft separated from the ct sheath hemostasis valve with the proximal tip protruding from the access site.Due to the patient's positioning, the medical team did not notice the sheath was leaking blood immediately.As a result of the blood loss, the patient's hemoglobin dropped from 12g/dl to 9g/dl, however the patient did not show signs of deterioration.The patient remained stable, and the procedure was completed without issues after the ct sheath was replaced.Post procedure, the patient received a blood transfusion due to the hemoglobin drop and was transferred to the intensive care unit (icu) to recover.
Additional Manufacturer Narrative
The clottriever sheath, 13 fr (ct sheath) was returned to the manufacturer and evaluated.Visual inspection confirmed the shaft separated from the swivel hub.Corrective action was opened to further investigate and determine potential root cause.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.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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 22470686
• Report Number: 3020347218-2025-00046
• Device Sequence Number: 7904872
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)260822(10)24080113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2025
• Device Model Number: 50-101
• Device Lot Number: 24080113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: CLOTTRIEVER BOLD CATHETER; FLOWSAVER; PROTRIEVE SHEATH; REVCORE CATHETER; TRIEVER16 CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male