MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0033594112

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 04/03/2024

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

It was reported that during a cardiac ablation procedure to treat paroxysmal atrial fibrillation using a farawave pulsed field ablation catheter the patient experienced a drop in blood pressure, pericardial effusion, cardiac tamponade, and perforation of the left atrial appendage.Transseptal access was achieved using a versacross connect system with the faradrive sheath, then a non-boston scientific multi-spline mapping catheter was inserted to collect left atrial geometry.The farawave catheter with a boston scientific distributed guidewire was inserted and ablation of the left pulmonary veins was performed without issue.However, after this a drop in blood pressure was detected.An intracardiac echo was performed and a pericardial effusion was noticed immediately.Instant methods were employed to relieve the blood drainage into the pericardial space, including pericardiocentesis where several hundred cc of blood was collected.Once the effusion was greatly reduced, the patient was transferred to cardiac surgery, where a sternotomy was performed and two small holes in the left atrial appendage were detected.It is unknown whether this occurred as a result of the transseptal puncture, multi-spline mapping catheter manipulation, or farawave catheter/wire manipulation.The procedure was not able to be completed due to the patient complications.The patient was held afterwards for observation, but is expected to recover.The device is not expected to be returned for analysis due to disposal.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19198753
• MDR Text Key: 341236637
• Report Number: 2124215-2024-24710
• 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
• Report Date: 04/26/2024

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: 0033594112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Race: White