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 Arrhythmia (1721); Atrial Fibrillation (1729); Tachycardia (2095)

Event Date 01/25/2024

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

Pf114 faradise clinical study, subject id: (b)(4).It was reported that after an irreversible electroporation ablation procedure using a farawave catheter to treat atrial fibrillation (a fib) the patient presented to the emergency room with re-occurrent atrial fibrillation (a fib).When the a fib was identified, the patient was admitted to the hospital and a cardioversion was performed to restore the sinus rhythm.Supraventricular tachycardia was seen for eight beats after the shock before the patient's rhythm normalized.They were discharged from the hospital that same day.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.

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

(b)(6) faradise clinical study, subject id: (b)(6).It was reported that after an irreversible electroporation ablation procedure using a farawave catheter to treat atrial fibrillation (a fib) the patient presented to the emergency room with re-occurrent atrial fibrillation (a fib).When the a fib was identified, the patient was admitted to the hospital and a cardioversion was performed to restore the sinus rhythm.Supraventricular tachycardia was seen for eight beats after the shock before the patient's rhythm normalized.They were discharged from the hospital that same day.The catheter is not expected to be returned as the complication emerged after the procedure, when the catheter would have been discarded.It was further reported that a repeat ablation for the a fib reoccurrence took place two months later.They were hospitalized overnight for the procedure, which was completed with no further patient complications.

• 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: 18712661
• MDR Text Key: 335527695
• Report Number: 2124215-2024-09042
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 02/15/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/10/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 69 KG