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

Device Problem Off-Label Use (1494)

Patient Problems Arrhythmia (1721); Pericardial Effusion (3271)

Event Date 09/04/2023

Event Type  Injury  

Manufacturer Narrative

Bianchini, l., moltrasio, m., fassini, g., cellucci, s., sicuso, r., ribatti, v., dessanai, m.A., pizzamiglio, f., vettor, g., majocchi, b., tundo, f., riva, s., carbucicchio, c., & tondo, c.(2023).Pulsed-field ablation of pulmonary vein and left atrial posterior wall combined with left atrial appendage occlusion as single procedure.Pacing and clinical electrophysiology.Https://doi.Org/10.1111/pace.14823.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

It was reported the patient experienced a mild pericardial effusion and short, repetitive atrial premature beats episodes.A 69-year-old man affected by long-standing persistent, symptomatic, drug-refractory atrial fibrillation (af) previously treated with two consecutive radiofrequency pvi (pulmonary vein isolation) procedures, was treated for a third time with a farawave catheter.Patient was also deemed to be at high hemorrhagic risk, so it was decided to perform simultaneously a left atrial appendage (laa) occlusion as a combined procedure.After general anesthesia induction, single transseptal puncture was performed.The farawave ablation catheter, through the 14f steerable sheath, was advanced in the left atrium.During ablation, pulmonary vein (pv) re-isolation was then achieved using the standard workflow (4 basket-like and 4 flower-like applications for each pv).Subsequently, after retracting the guidewire, in the flower-like configuration, under the guidance of voltage map and fluoroscopy, 12 consecutive applications were deployed, targeting the whole area of the left atrium posterior wall (lapw).Complete lapw ablation was completed in 10 min.Afterwards, left atrium high density voltage map was done using an intellamap orion catheter and pvi, as well as lapw ablation, were validated.Finally, the 14f deflectable sheath was replaced by the 14f dedicated sheath for watchman flex deployment.Under intracardiac echocardiography and selective angiography guide to determine device size, successful laa closure was performed with no final residual flow.No major procedural complications were detected.Mild pericardial effusion was noticed at echocardiography check 48 h after procedure and was stable after further 24 h of observations.Short repetitive atrial premature beats episodes were observed the day after the procedure, with subsequent stabilization of sinus rhythm after amiodarone infusion.Antithrombotic therapy at discharge consisted of non-vitamin k antagonist oral anticoagulant (noac) plus aspirin.Bianchini, l., moltrasio, m., fassini, g., cellucci, s., sicuso, r., ribatti, v., dessanai, m.A., pizzamiglio, f., vettor, g., majocchi, b., tundo, f., riva, s., carbucicchio, c., & tondo, c.(2023).Pulsed-field ablation of pulmonary vein and left atrial posterior wall combined with left atrial appendage occlusion as single procedure.Pacing and clinical electrophysiology.Https://doi.Org/10.1111/pace.14823.

• 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: 19003584
• MDR Text Key: 338902534
• Report Number: 2124215-2024-18100
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 03/07/2024
• Initial Date FDA Received: 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