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

Model Number	10-104
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 67-year-old male patient with a bilateral pulmonary embolism (pe) underwent a thrombectomy procedure with the inari flowtriever (ft) system on (b)(6) 2023.The patient had been symptomatic for 3 weeks and the clot age was 21 days.During the procedure, the ft xl disks were inserted into the triever24 (t24) catheter.After advancing approximately 20 centimeters, the physician felt resistance and the xl disks were withdrawn from the patient.The amplatz superstiff guidewire became dislodged, so a multipurpose catheter was used inside of the t24 to re-wire.While pushing the multipurpose catheter to the distal end of the t24, a loose radiopaque marker was identified using fluoroscopy and pulled into the right lower lobe artery.The marker had inadvertently detached from the ft xl disk.Multiple attempts were made to remove the marker, including aspiration with the t24 and use of a spider basket.Retrieval efforts continued for one hour, but unfortunately, the marker was unable to be removed and the physician elected to leave the marker inside the lower lobe segmental artery.The patient was stable throughout the entire procedure and approximately 80% of the clot was removed.The patient was transferred back to the intensive care unit and follow-up has been requested.
Additional Manufacturer Narrative
The flowtriever xl disk is being returned to the manufacturer for evaluation.The findings will be submitted in a follow-up report.The event was reviewed by inari's chief medical officer, who concluded that the detached marker was the result of device malfunction.Manufacturer reference#: (b)(4).
Additional Manufacturer Narrative
The flowtriever (ft) catheter, xl, and ft delivery catheter were returned to the manufacturer for evaluation.The device was subjected to visual inspection, dimensional analysis, and physical testing.Only the distal portion of the very distal black tip on the braided elements was missing.The 0.202" length of the tip remained intact and fully bonded to the device.The disks were deployed from the ft delivery catheter and images were taken of the braided elements and of the break site at distal tip.There was no observable damage to the ft delivery catheter.A bend test was performed on the distal tip of the ft xl catheter which revealed the material was more brittle than typical extrusions, indicative of potential material irregularities.The brittle distal tip made it more prone to breakage and was therefore unable to withstand the brief period of applied force when resistance was felt.Review of the device history records for this manufacturing lot did not identify an out of specification condition.The device labeling includes the following warning statement: avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract and collapse the distal disks into the catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation.
Event or Problem Description
Additional information was provided by the company representative who was present during the surgery and it was learned that excessive force was briefly applied when advancing the ft disks.The surgeon stopped advancing within seconds of feeling resistance, but by that time the distal tip had already dislodged.Additional information has been requested on the patient's status, but no new information has been provided.

• Brand Name: FLOWTRIEVER CATHETER, XL
• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17218158
• Report Number: 3020347218-2023-00010
• Device Sequence Number: 16899822
• Product Code: QEW
• UDI-Device Identifier: 00850291007055
• UDI-Public: 00850291007055
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 04/20/2024
• Device Model Number: 10-104
• Device Lot Number: 22040049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: AMPLATZ SUPERSTIFF GUIDEWIRE 1 CM; COOK SHEATH 24 FR; INARI TRIEVER24 CATHETER; J TIP 260 CM STEELWIRE; PIGTAIL CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 120 KG