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

Model Number	21-101
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Hemoptysis (1887)
Date of Event	12/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The 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.Damage to the hemostasis valve (hissing sound) was not believed to be responsible for the hemoptysis.According to the inari medical consultant's expert opinion, the patient bled to death due to hemoptysis caused by perforation; the likely source was either guidewire perforation or vacuum aspiration damaging the vessel wall.Hemoptysis and death are listed in the device labeling as potential complications associated with thrombectomy procedures.Manufacturer reference #: (b)(4).
Event or Problem Description
On (b)(6) 2018, a late-stage multiple myeloma patient with metastatic cancer presented in the emergency department with dyspnea and dizziness.Ct angiography confirmed a saddle, bilateral pulmonary embolus.His right ventricle/left ventricle (rv/lv) ratio was elevated at 1.5, 2l of oxygen, hr: 92, bp: 112/77, and pulmonary artery pressure was elevated at 50/26/36 (systolic/diastolic/mean mmhg).The history of prior chest radiation was unknown.The patient was transferred to the "catherization" laboratory where the interventional cardiologist gained access through the groin using the aspiration guide catheter (agc) via ultrasound and crossed the heart with a pigtail catheter.Hemodynamic measurements and pulmonary angiography revealed a proximal thrombus in the truncus anterior and middle lobar segments.Blood pressure became unstable.The pigtail catheter was replaced with the amplatz superstiff guidewire.Starting in the right pulmonary artery (pa), an acute/chronic clot was extracted via aspiration with the 60 cc syringe (supplied as part of the agc system).The truncus anterior was obstructed, preventing guidewire access.The agc was reinserted and placed into the left pa, but no clot was extracted.The agc was reinserted into the right pa and the saddle clot was aspirated with the 60 cc syringe.The agc was positioned to the left pa; the guidewire was retracted into agc and vacuum was pulled with the 60 cc syringe; at this time a hissing sound was heard with cavitation noted in the syringe.The patient coughed then started coughing up a large volume of blood, estimated at 300-500 cc; heparin was discontinued and protamine administered.The patient deteriorated further, arrested, and a code was called.During resuscitation, a pulse was regained.Bronchoscopy and pulmonary angiography on right side did not reveal the source of bleeding.The patient arrested again and cpr was administered and a pulse was regained temporarily; however, the patient arrested a third time.Cpr continued for approximately one hour, but the team was unable to regain a pulse and the patient expired.Final pulmonary angiogram did not reveal extravasation.

• 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: 8197150
• Report Number: 3011525976-2018-00003
• Device Sequence Number: 16622664
• 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): 12/26/2018

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: 10/10/2020
• Device Model Number: 21-101
• Device Lot Number: 18100001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PIGTAIL CATHETER, AMPLATZ SUPERSTIFF GUIDEWIRE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Weight: 86