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

Device Problems Entrapment of Device (1212); Off-Label Use (1494)

Patient Problem Cardiac Tamponade (2226)

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that the catheter guidewire exhibited resistance when moving and the patient experienced cardiac tamponade.During a pulmonary vein isolation (pvi) isolation procedure to treat atrial fibrillation using a farawave pulsed field ablation catheter and a faradrive steerable sheath clear the patient experienced cardiac tamponade.Transeptal access was lost, so a rewire was done and the faradrive sheath was forced across the septum without dilation.After regaining transseptal access the guidewire seemed stuck or had more resistance when moving.The sheath location was checked on intracardiac echocardiography (ice), but the guidewire was never visible.The wire was tracked via fluoroscopy in multiple views, and it was suggested that the catheter and wire be removed and inspected due to the noted resistance.The physician decided to move ahead without that verification though.A check for effusion was made and a cardiac tamponade was discovered.The procedure was cancelled to address the complication, and pericardiocentesis and open-heart surgery were performed.The patient was hospitalized but is expected to make a full recovery.The device is expected to be returned for analysis.

Manufacturer Narrative

B5: describe event or problem - updated.H6: device codes- updated.

Event Description

It was reported that the catheter guidewire exhibited resistance when moving and the patient experienced cardiac tamponade.During a pulmonary vein isolation (pvi) isolation procedure to treat atrial fibrillation using a farawave pulsed field ablation catheter and a faradrive steerable sheath clear the patient experienced cardiac tamponade.Transeptal access was lost, so a rewire was done and the faradrive sheath was forced across the septum without dilation.After regaining transseptal access the guidewire seemed stuck or had more resistance when moving.The sheath location was checked on intracardiac echocardiography (ice), but the guidewire was never visible.The wire was tracked via fluoroscopy in multiple views, and it was suggested that the catheter and wire be removed and inspected due to the noted resistance.The physician decided to move ahead without that verification though.A check for effusion was made and a cardiac tamponade was discovered.The procedure was cancelled to address the complication, and pericardiocentesis and open-heart surgery were performed.The patient was hospitalized but is expected to make a full recovery.The device is expected to be returned for analysis.It was further reported that the catheter was used off-label to perform a pulmonary wall ablation before the procedure was cancelled.The location of the cardiac tamponade was in the roof of the left atrium (la).

• 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): CENTERPOINT SYSTEMS; west valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19182754
• MDR Text Key: 341059667
• Report Number: 2124215-2024-24999
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening