MAUDE Adverse Event Report: INARI MEDICAL, INC. INARI FLOWTRIEVER CATHETER, M; EMBOLECTOMY CATHETER

Model Number	10-102
Health Effect - Clinical Codes	Anemia (1706); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Hypovolemia (2243)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
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 company recorded all lots shipped to the facility and each of the possible lot history records were reviewed.There were no discrepancies or unusual findings.There was no report of any device malfunction.According to the initial reporter, the event was attributed to use error.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The flowtriever catheter instructions for use lists the following warnings: warning: excess pressure may result in catheter damage or patient injury.Warning: 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.This mdr is for the inari flowtriever catheter device.Refer to mdr #3011525976-2021-00008 and #3011525976-2021-00009 for the other 2 inari devices involved in this event.Manufacturer reference #: (b)(4).
Event or Problem Description
A (b)(6) female patient with chronic pancreatitis presented to the emergency department with hypertension and suspected acute myocardial infarction (mi).She was diagnosed with a pulmonary embolism (pe) after undergoing a right heart catheterization and pulmonary angiogram (acute mi was ruled out).On (b)(6) 2021, the inari triever16 (t16), triever20 (t20), and medium flowtriever (ft) disks were used to attempt to treat the pe.The patient remained hypertensive and tachycardic throughout the mechanical thrombectomy, with markedly elevated right-sided pulmonary and atrial pressures.The clot in the right pulmonary artery was successfully aspirated, but clot remained in the left lower lobe (lll) despite use of the t20, t16, and medium ft disks.An ekos catheter was placed due to the persistent tachycardia, and the case was concluded.The following day, right heart catheterization revealed resolution of right ventricle failure and normalization of right atrial pressure (~20 reduced to ~6 mmhg).The patient's tachycardia and nausea persisted, and the hgb level decreased from 9 to 7 gm/dl due to 600 cc of blood being aspirated during the procedure.The patient was infused with 2 units of blood, quinidine therapy was discontinued, and a computed tomography angiogram (cta) was ordered.The initial cta findings indicated a pseudoaneurysm at the location of intervention in the lll basal segments, but the performing physician interpreted the result as an intramural hematoma.The physician reported using an "assertive" technique due to the patient's unimproved hemodynamic state.After monitoring, the patient's hgb level increased to 9 gm/dl, quinidine and blood pressure medications were resumed, and she was discharged within a few days with marked improvement compared to original presentation.A follow-up cta is scheduled for 3-6 months postoperatively.The findings from a cta performed on (b)(6) 2021 indicated an improvement.

• Brand Name: INARI FLOWTRIEVER CATHETER, M
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9 parker; suite 100; irvine CA 92618
• MDR Report Key: 11336350
• Report Number: 3011525976-2021-00010
• Device Sequence Number: 4502505
• Product Code: QEW
• UDI-Device Identifier: 00850291007017
• UDI-Public: 00850291007017
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10-102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85