MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 35MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0008021480

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

Patient Problems Dyspnea (1816); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 01/26/2024

Event Type  Injury  

Event Description

It was reported that after a procedure using a farawave pulsed field ablation catheter the patient presented to the emergency department on (b)(6) 2024 with complaint of dyspnea and finger muscle cramps.A computed tomography (ct) scan of the thorax was performed which revealed signs of cardiac decompensation with multiple focal matrices bilaterally, bilateral pleural fluid (right more than left), accentuation of interlobular septa, cardiomegaly and plump pulmonary vasculature.No pericardial fluid was observed.2mg of an intravenous diuretic were given.A transthoracic echocardiogram (tte) was also performed showing decompensation with valve deficiencies, along with permanently impaired cardiac function.The patient was started on 25mg of a different diuretic.The patient was hospitalized.On (b)(6) 2024 the patient was started on 2.5 mg of an oral diuretic, 2.5mg of an angiotensin-converting enzyme (ace) inhibitor, and 10mg of an anti-diabetic enzyme inhibitor.On (b)(6) 2024 an x-ray scan of the thorax was performed showing cardiomegaly and limited pleural fluid right basal.There were no confluent pulmonary compressions and no pneumothorax alignable.Signs of chronic obstructive pulmonary disease (copd) were also observed.On (b)(6) 2024 the patient had swelling of the lips due to the previously prescribed ace inhibitor, which was then replaced with 50mg of an antihypertensive drug.The patient was also given 40mg of a steroid and 10mg of an antihistamine.The patient was discharged from the hospital on 01feb2024 with the complication resolved.The device is not expected to be returned for analysis.Clinical study name: faradise, clinical study id: (b)(6), clinical patient id: (b)(6).

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, 35MM
• 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: 18818672
• MDR Text Key: 336737150
• Report Number: 2124215-2024-08143
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

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: 0008021480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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): Hospitalization; Disability; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 69 KG