MAUDE Adverse Event Report: INARI MEDICAL, INC. FLOWTRIEVER RETRIEVAL ASPIRATION SYSTEM; EMBOLECTOMY CATHETER

Model Number	21-101
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Airway Obstruction (1699); Hemoptysis (1887); Perforation of Vessels (2135)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari device was discarded by the user facility and is therefore not available for analysis.The device history records for this manufacturing lot were reviewed and there were no anomalies, discrepancies, or non-conformances.There was no report of a device malfunction.The medical monitor review by inari concluded that the patient's hemoptysis was caused by vessel perforation with guidewire perforation (use error) as the likely source.Hemoptysis and vessel perforation are listed in the device labeling as potential complications associated with thrombectomy/embolectomy procedures.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2019, a patient with a history of deep vein thrombosis and cancer presented to the emergency department with dyspnea; ct angiography confirmed bilateral pulmonary embolus.The patient was transferred to the catheterization laboratory where the interventional cardiologist gained access through the groin using the inari aspiration guide catheter (agc) via ultrasound and crossed the heart.After accessing the right pulmonary artery (pa), the access guidewire was exchanged for a 0.035" terumo 260 cm glidewire advantage.A proximal thrombus was cleared from right side with via aspiration using the inari 60 cc syringe (supplied with the agc).The inari agc was then reinserted and placed into the left pa.The terumo glidewire was placed mid lobe, just beyond the clot burden.After an unsuccessful aspiration through the agc, the patient had an episode of severe hemoptysis.The patient was subsequently intubated, but no extravasation was noted.Heparin was discontinued and protamine was administered.The gastrointestinal workup ruled out stomach bleeding; bronchoscopy on the left side noted blood in the airway.The treating physician concluded that a micro vessel on left side had perforated.After the incident the patient was transferred to the intensive care unit.The following day the patient was doing well, was extubated and breathing room air.No device malfunction was reported.

• Brand Name: FLOWTRIEVER RETRIEVAL ASPIRATION SYSTEM
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• MDR Report Key: 8685303
• Report Number: 3011525976-2019-00002
• Device Sequence Number: 16642581
• Product Code: DXE
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2019

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 Expiration Date: 10/31/2020
• Device Model Number: 21-101
• Device Lot Number: 18100008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/10/2019
• 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; Required Intervention
• Patient Age: 72 YR