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	Foreign Body In Patient (2687)
Date of Event	01/23/2025
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.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.A complaint history review was conducted and no similar issues have been reported against this lot number.Manufacturer reference #: (b)(4).
Event or Problem Description
An individual underwent a thrombectomy using the inari clottriever (ct) system to treat their right lower extremity deep vein thrombosis.After wire positioning was accomplished using a 260cm glide advantage wire, a 13 fr.Ct sheath was opened and prepped.An 8 fr.Sheath was removed and the inari prepackaged pre-dilator was utilized to dilate the access site.The dilator was removed and the 13fr.Sheath was inserted.The ct sheath was deployed in normal order and the mounted dilator was removed.The ct catheter was prepped and then inserted.2 passes were made which yielded clot.At this point, the glide advantage wire was noted to have moved backwards and so the physician elected to re-position.Imaging was performed when a small "cone shaped" radiopaque object was seen.Based on its size, it was concluded that it was not the tip of the ct catheter.Inspection began on all products that were utilized up to that point.This was when it was noticed that the ct sheath's dilator was missing its tip.The physician began to slowly pull back the guidewire as the tip appeared to be slightly fixed to the end, however, the tip dislodged and migrated to a sub-segmental branch in the right pulmonary artery.The physician determined that the risk of recapturing the material was of greater risk than complications associated with leaving it in.The thrombectomy was completed with 2 additional passes with the ct catheter and the case was considered complete.The patient was hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
The clottriever sheath 13 fr.Was returned to the manufacturer and evaluated.The clottriever dilator was returned without the sheath and with the tip separated.A visual inspection was performed in which the tip failure was viewed under microscope and the pebax tube was seen inside the over molded pebax outer layer.The pebax over mold fractured nearly flush to the end, with only a small, raised area, indicating the fracture was brittle rather than ductile.No evidence of contamination was found in the fracture area.Attempts were made to replicate the complaint failure on other 13fr clottriever dilators.Significant shear and tensile stress were applied to the tip using pliers while clamping the tube over mold area.The tip was unable to be separated using manual force, and instead the tip only exhibited plastic deformation around the tip connection.Another 13fr dilator was tested using a tensile test stand to attempt to separate the tip from the rest of the over mold.The tip exhibited plastic deformation in this test as well, however the over mold sleeve fully detached from the shaft without any sign of separation between the tip and over mold sleeve.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.All raw material lots were also found to be within dimensional specifications per the receiving records, and these critical dimensions were also measured on the returned complaint units and found to be within specification.The most probable root cause is insufficient over mold parameters or setup.When attempting to replicate the failure, dilators that passed all product specifications could not be broken at the tip in a brittle fracture as observed in the complaint.The tip on these test samples instead exhibited ductility and plastic deformation.Therefore, the most likely scenario is that a material weakness inherent in the over mold propagated into a brittle failure at a much lower force.

• 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 ; 9494132147
• MDR Report Key: 21429013
• Report Number: 3020347218-2025-00014
• Device Sequence Number: 4349100
• Product Code: QEW
• UDI-Device Identifier: 00850291007109
• UDI-Public: (01)00850291007109(17)260815(10)24080075
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 08/15/2026
• Device Model Number: 50-101
• Device Lot Number: 24080075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 260CM GLIDE ADVANTAGE WIRE; CLOTTRIEVER BOLD CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown