MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER XL CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	41-102
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a 57-year-old female underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient had clot in the suprarenal inferior vena cava (ivc) that was estimated to be two days old.The patient had undergone dvt thrombectomy the day prior on (b)(6) 2025, where the inari flowtriever system was used to attempt to aspirate the clot, but was unsuccessful.During the dvt thrombectomy on (b)(6) 2025, the clottriever xl catheter (ct xl) collection bag collected a large amount of dense clot which prevented the collection bag from retracting into the catheter.The medical team attempted to remove the ct xl and introducer sheath together, however the sheath was inadvertently removed, leaving the ct xl in the patient's vessel.The medical team was then able to remove the ct xl by performing an additional skin nick and removing the device with clamps.The patient did not require additional surgery and intravascular ultrasound (ivus) was run where it was noted the majority of clot was removed with no venous injury.The patient did not decompensate throughout the duration of the procedure and was stable post procedure.
Additional Manufacturer Narrative
The inari devices were discarded by the user facility and are not available for evaluation.The device identifiers were not provided, however, the lot history records of all potential lots shipped to the facility were reviewed and there were no discrepancies or unusual findings.The device labeling includes the following warning statements: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." "examine the clottriever xl catheter prior to insertion to verify it is not damaged." "ensure that clottriever xl catheter is withdrawn into the clottriever thrombectomy system sheaths prior to removal from patient to avoid vascular damage." vasospasm is listed in the device labeling as a possible adverse event/complication.Manufacturer reference: (b)(4).

• Brand Name: CLOTTRIEVER XL CATHETER
• 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: 21375949
• Report Number: 3020347218-2025-00010
• Device Sequence Number: 8432307
• Product Code: QEW
• UDI-Device Identifier: 00850291007277
• UDI-Public: 00850291007277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K242557
• 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): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41-102
• 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: 01/17/2025
• Initial Report FDA Received Date: 02/13/2025
• 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: CLOTTRIEVER SHEATH, 16FR
• Patient Age: 57 YR
• Patient Sex: Female