MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0008021715

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

Patient Problem Syncope/Fainting (4411)

Event Date 01/29/2024

Event Type  Injury  

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

Faradise clinical study subject id (b)(6).It was reported that during a pulse field ablation (pfa) procedure using a farawave pfa catheter the patient experienced a vasovagal reaction.Atropine and temporary pacing were administered.Information regarding the procedure or patient outcome was not provided.It is unknown if the catheter will be returned for analysis.

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

Faradise clinical study subject id (b)(6).It was reported that the patient experienced vasovagal reaction during the pulsed field ablation procedure.Atropine and temporary pacing were administered.No additional information is available.It was additionally reported that the vasovagal resolved during the procedure.The ablation procedure was successfully completed with no patient complications.The catheter was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• 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 H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19218509
• MDR Text Key: 341458017
• Report Number: 2124215-2024-26392
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: MN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Lot Number: 0008021715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 63 KG