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

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

Patient Problem Pleural Effusion (2010)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical study advantage af phase 2 for (b)(6); subject id: (b)(6).It was reported that the patient experienced shortness of breath and pleuritic chest pain twice a day beginning (b)(6) 2024, post an ablation procedure which occurred on (b)(6) 2024, using a farawave ablation catheter.The patient visited the emergency room (er) and was diagnosed with pleural effusion.The patient's medication was adjusted.Additional testing of chest x-ray, ct- scan, laboratory testing for blood work, and electrocardiogram were performed.The patient was discharged against medical advice.The patient's condition is ongoing as the physician's request for them to return to the er for further assessment was declined.The device has been discarded.

• Brand Name: FARAWAVE 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: 18686616
• MDR Text Key: 335187704
• Report Number: 2124215-2024-07694
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

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: 01/25/2024
• Initial Date FDA Received: 02/12/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG