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

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

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

This event is being reported for aborted/cancelled procedure with a patient under sedation.During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a farawave catheter was selected for use.After successful ablation of one pulmonary vein an issue occurred with the non-boston scientific guidewire that was used with the catheter.The procedure was cancelled.No patient complications were reported.It is unknown if the catheter will be returned for analysis.

Manufacturer Narrative

Correction to the initial mdr in block b5-describe event or problem.

Event Description

This event is being reported for aborted/cancelled procedure with a patient under sedation.During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a farawave catheter was selected for use.After successful ablation of one pulmonary vein an issue occurred with the non-boston scientific guidewire that was used with the catheter.The procedure was cancelled.No patient complications were reported.It is unknown if the catheter will be returned for analysis.It was further reported that the non-boston scientific guidewire became trapped in a distal vessel of the lung, it took a 90degree angle and the braiding entrapped tissue.The farawave catheter was still able to move along the wire.The farawave catheter did not contribute to the entrapment of the wire within the tissue.The wire trapped in tissue meant that the physician had to cancel the procedure and prepare for the risk of surgery during wire removal.The event or cancel procedure was not related to the farawave catheter.

• 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): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19071691
• MDR Text Key: 339897221
• Report Number: 2124215-2024-21490
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/09/2024
• 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