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 Pulmonary Embolism (1498); Dyspnea (1816); Pulmonary Edema (2020)

Event Date 02/01/2024

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

Clinical study name: advantage af phase 2, clinical study id: (b)(6), clinical patient id: (b)(6).It was reported that during the 7-day routine follow-up after a procedure using a farawave ablation catheter the patient presented with possible pulmonary edema.Mild crackles upon lung auscultation from the patient were noted, and the patient also reported worsening shortness of breath.The patient was prescribed a diuretic medication to be taken daily for four days by mouth.The current status of the patient is unknown.It is unknown if the device will be returned for analysis.

Event Description

Clinical study name: advantage af phase 2, clinical study id: pf106, clinical patient id: (b)(6).It was reported that during the 7-day routine follow-up after a procedure using a farawave ablation catheter the patient presented with possible pulmonary edema.Mild crackles upon lung auscultation from the patient were noted, and the patient also reported worsening shortness of breath.The patient was prescribed a diuretic medication to be taken daily for four days by mouth.The current status of the patient is unknown.The device is not expected to be returned for analysis.It was further reported that the pulmonary edema resolved 25 days after onset.

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.H6 evaluation conclusion codes corrected from cmc - known inherent risk of device to cmc - conclusion not yet available.H6 patient code corrected from e050303 pulmonary embolism to e0736 pulmonary edema.

Event Description

It was reported that during the 7-day routine follow-up after a procedure using a farawave ablation catheter the patient presented with possible pulmonary edema.Mild crackles upon lung auscultation from the patient were noted, and the patient also reported worsening shortness of breath.The patient was prescribed a diuretic medication to be taken daily for four days by mouth.The current status of the patient is unknown.It is unknown if the device will be returned for analysis.Clinical study name: advantage af phase 2 clinical study id: (b)(6), clinical patient id: (b)(6).It was further reported that the device is not expected to be returned for analysis.The pulmonary edema is ongoing.

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 (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: 18680003
• MDR Text Key: 335072818
• Report Number: 2124215-2024-07332
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

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: 02/02/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/09/2024; 03/07/2024
• Supplement Dates FDA Received: 03/06/2024; 03/29/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 110 KG