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 Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been retained at the hospital and is not available for evaluation.If the device is returned, a follow up report will be submitted.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 the following warning: "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).
Event or Problem Description
On (b)(6) 2025, a 24-year-old male underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient was being treated for testicular cancer and a history of pulmonary embolism that was treated in (b)(6) 2025.The patient had a mass in his left common iliac, which totally occluded the vein.The patient's clot age was estimated at 60 days.Extravasation was observed after the clottriever sheath, 13fr (ct sheath) was inserted into the patient's left popliteal vein and an attempt was made to advance the clottriever bold.The medical team made the decision to use the patient's internal jugular vein as an access site.While the new ct sheath was being placed into the patient's internal jugular, the medical team noticed the dilator was bending while being inserted.The ct sheath was advanced, and the funnel was deployed.A venogram showed some extravasation.An attempt was made to track a balloon over the wire; however, the balloon could not be advanced.The medical team decided to use another sheath and while removing the ct sheath, the physician noticed the funnel was no longer connected to the distal end of the ct sheath.Fluoroscopy imaging revealed that the funnel remained in the patient's vein.Multiple attempts were made to remove the funnel; however, the medical team was unable to retrieve it.Imaging revealed that the funnel was non-occlusive and did not limit blood flow.The decision was made to leave the funnel in the venotomy and continue the procedure.A treiver20 was used to remove a significant portion of clot from the patient's iliac, great saphenous vein, and femoral vein.Two stents were placed, and the patient had restored flow.During a follow-up appointment, the patient's leg swelling had significantly been reduced, and the medical team did not elect to complete further treatment to remove the funnel.

• 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: 22377471
• Report Number: 3020347218-2025-00043
• Device Sequence Number: 4617163
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)261118(10)24110107
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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 Model Number: 50-101
• Device Lot Number: 24110107
• 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: 06/06/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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; TREIVER20 CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male