MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericarditis (4448)

Event Date 01/11/2024

Event Type  Injury  

Event Description

Advantage af phase 2 clinical study id: (b)(6), patient id: (b)(6).It was reported that a following a pulse field ablation procedure involving an farawave catheter, the patient presented with pericarditis.Patient reported chest pressure with exertion and when lying down after being discharged home.Patient was advised to take colchicine until symptoms resolved and to have an echocariogram.No device allegation reported.Product return is not expected as the event occurred post procedure.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Advantage af phase 2 clinical study id: (b)(6), patient id: (b)(6).It was reported that a following a pulse field ablation procedure involving an farawave catheter, the patient presented with pericarditis.Patient reported chest pressure with exertion and when lying down after being discharged home.Patient was advised to take colchicine until symptoms resolved and to have an echocariogram.No device allegation reported.Product return is not expected as the event occurred post procedure.It was further reported that echocardiogram was performed and the event was resolved on (b)(6)2024.

• Brand Name: FARAWAVE
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18653325
• MDR Text Key: 334692294
• Report Number: 2124215-2024-06597
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 54 KG