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

Model Number	40-102
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Perforation (2513); Diminished Pulse Pressure (2606); Vascular Dissection (3160); Pericardial Effusion (3271); Respiratory Arrest (4461)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Inari received a voluntary medwatch report (#mw5146512) which stated "inari thrombectomy device used in svc/brachiocephalic trunk to remove suspected clot burden.Svc [superior vena cava] was dissected and hole into the pericardium.Patient lost pulses, cpr was administered.Patient was intubated.Pericardiocentesis was performed via echo [echocardiogram] which showed the rv [right ventricle] was barely functioning.250cc's of blood was taken off of the heart".
Additional Manufacturer Narrative
The inari devices were not returned for evaluation and the medwatch report lacked sufficient information to enable follow-up with the user facility to request the suspect device.The case was reviewed by inari's chief medical officer, who supsects that the event was likely the result of wire perforation, however the description of the event lacks adequate detail to determine a causal relationship.Vessel dissection, vessel perforation, and cardiovascular collapse are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).

• Brand Name: CLOTTRIEVER 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: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18196734
• Report Number: 3020347218-2023-00021
• Device Sequence Number: 15091629
• Product Code: QEW
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 40-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown