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

Lot Number 0008021760

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

Patient Problem Chest Pain (1776)

Event Date 02/07/2024

Event Type  Injury  

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

Faradise clinical study, clinical study id: (b)(4), clinical patient id: (b)(6).It was reported that after an ablation procedure using a farawave pulsed field ablation catheter the patient experienced chest pain suspected to have been caused by phrenic nerve irritation.The patient was hospitalized and a transthoracic echocardiogram (tte) was performed to rule out pericardial effusion.Electrocardiogram showed no abnormalities.The chest pain was not sufficiently reduced with paracetamol.The patient was given 50 mcg of fentanyl, after which the pain decreased.The patient was discharged the next day in good health.The device is not expected to be returned for analysis.

Event Description

Faradise clinical study, clinical study id: (b)(6), clinical patient id: (b)(6).It was reported that after an ablation procedure using a farawave pulsed field ablation catheter the patient experienced chest pain suspected to have been caused by phrenic nerve irritation.The patient was hospitalized and a transthoracic echocardiogram (tte) was performed to rule out pericardial effusion.Electrocardiogram showed no abnormalities.The chest pain was not sufficiently reduced with paracetamol.The patient was given 50 mcg of fentanyl, after which the pain decreased.The patient was discharged the next day in good health.The device is not expected to be returned for analysis.It was reported that the patient was also administered oxycodone and oxazepam to help with pain and stress relief.

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, 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: 18748222
• MDR Text Key: 335935201
• Report Number: 2124215-2024-09990
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 03/07/2024

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: 0008021760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 100 KG