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

Model Number	43-102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a 60-year old female underwent deep vein thrombosis (dvt) thrombectomy using inari devices.The patient's clot age was estimated at 45 days.The patient had a history of cancer and had a port in the superior vena cava (svc).Upon arrival at the hospital, the patient had a complete obstruction in their catheter port and no flow to the svc.During the thrombectomy, clot was removed with the first pass of the enthrall thrombectomy catheter (enthrall).The medical team was unable to remove all the clot from the intrhill coring element using the included element support tool and wipes, thus the medical team used forceps to remove the last pieces of clot that were adhering to the coring element.The medical team then noticed a nitinol element strut on the inthrill coring element appeared to be severed from the rest of the basket and was sticking out.The medical team attempted to resheath the device, however the wire could not be resheathed into the catheter.A new device was opened to complete the case and there was no injury to the patient.
Additional Manufacturer Narrative
The inthrill thrombectomy catheter (inthrill) was returned to the manufacturer for evaluation.Following decontamination, a lab element support tool was used to fully open the coring element and inspect for damage.Only one strut was confirmed to be broken.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.Using the forceps to remove the remaining clot from the coring element likely caused the strut to break.Manufacturer reference #: (b)(4).

• Brand Name: INTHRILL THROMBECTOMY 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: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 22958180
• Report Number: 3020347218-2025-00057
• Device Sequence Number: 8404691
• Product Code: QEW
• UDI-Device Identifier: 00810123710126
• UDI-Public: (01)00810123710126(17)251014(10)25040064
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K250421
• 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): 09/03/2025

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 Expiration Date: 10/14/2025
• Device Model Number: 43-102
• Device Lot Number: 25040064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: INTHRILL SHEATH
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 79 KG