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

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vasoconstriction (2126); Syncope/Fainting (4411)

Event Date 02/16/2024

Event Type  Injury  

Event Description

It was reported that after an irreversible electroporation ablation procedure using a farawave catheter the patient experienced a coronary spasm.The procedure was completed successfully with no issues noted at that time.Approximately three to four hours after the procedure the patient experienced an acute coronary spasm.No interventions took place, and the patient is expected to fully recover.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that after an irreversible electroporation ablation procedure using a farawave catheter the patient experienced a coronary spasm.The procedure was completed successfully with no issues noted at that time.Approximately three to four hours after the procedure the patient experienced an acute coronary spasm.No interventions took place, and the patient is expected to fully recover.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.It was further reported that a coronarography was performed a few days after the case and nothing abnormal was observed.The patient is reported to be experiencing bradycardia, hypotension and faints easily when he walks.

Manufacturer Narrative

Correction to h1: type of reportable event based upon analysis of all available information, bsc's investigation found no evidence to indicate that the coronary spasm was related to product performance of the farawave catheter.There was no report of any device performance concerns.The complaint patient events reported are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.

Event Description

It was reported that after an irreversible electroporation ablation procedure using a farawave catheter the patient experienced a coronary spasm.The procedure was completed successfully with no issues noted at that time.Approximately three to four hours after the procedure the patient experienced an acute coronary spasm.No interventions took place, and the patient is expected to fully recover.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.It was further reported that a coronarography was performed a few days after the case and nothing abnormal was observed.The patient is reported to be experiencing bradycardia, hypotension and faints easily when he walks.

Manufacturer Narrative

Based upon analysis of all available information, bsc's investigation found no evidence to indicate that the coronary spasm was related to product performance of the farawave catheter.There was no report of any device performance concerns.The complaint patient events reported are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): AGILE MV INC; 3700 st patrick st; suite 102; montreal, qc ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18767572
• MDR Text Key: 336113085
• Report Number: 2124215-2024-10778
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 02/23/2024; 02/23/2024
• Supplement Dates FDA Received: 03/14/2024; 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other