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

Device Problem Off-Label Use (1494)

Patient Problem Syncope/Fainting (4411)

Event Date 03/18/2024

Event Type  Injury  

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 during an irreversible electroporation using a farawave catheter the patient experienced a vasovagal response.During the procedure a posterior wall ablation was performed, posterior wall ablations are considered off-label use for the farawave catheter.The farawave's instructions for use (ifu) sates that "the farawave catheter is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation".After the posterior wall ablation validation mapping found a delayed vagal response, as the patient was "unable to 1:1 conduct from atria to ventricles".The patient was able to "conduct down to 360ms" after an isuprel infusion.It is not currently known if the device will be returned for analysis.

Event Description

It was reported that during an irreversible electroporation using a farawave catheter the patient experienced a vasovagal response.During the procedure a posterior wall ablation was performed, posterior wall ablations are considered off-label use for the farawave catheter.The farawave's instructions for use (ifu) sates that "the farawave catheter is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation".After the posterior wall ablation validation mapping found a delayed vagal response, as the patient was "unable to 1:1 conduct from atria to ventricles".The patient was able to "conduct down to 360ms" after an isuprel infusion.It is not currently known if the device will be returned for analysis.It was further reported that the device was disposed of following the procedure and that the patient recovered without the need for any further treatments or interventions.

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.

• 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 Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19038780
• MDR Text Key: 339319433
• Report Number: 2124215-2024-20121
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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: Not provided
• Initial Date FDA Received: 04/03/2024
• 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): Required Intervention