MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE? NAV; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Lot Number	0039272031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later.Farawave was selected for use and during a transesophageal echocardiogram (tte), a pericardial effusion was noted.Patient was brought back into the room to get a pericardiocentesis.Pigtail versacross was used in the procedure.The patient has been discharged.The device is not expected to be returning as it has been disposed.
Event or Problem Description
It has been reported that bradycardia, pericardial effusion and cardiac tamponade occurred post procedure 3hrs later.Farawave was selected for use and during a transesophageal echocardiogram (tte), a pericardial effusion was noted.Patient was brought back into the room to get a pericardiocentesis.Pigtail versacross was used in the procedure.The patient has been discharged.The device is not expected to be returning as it has been disposed.
Additional Manufacturer Narrative
D2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.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.
Additional Manufacturer Narrative
Correction to section g2 report source d2a: common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as the common device name exceeded the character limit for designated field.Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of cardiac tamponade, pericardial effusion and bradycardia.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review a risk review performed for the farawave device confirmed that the event of cardiac tamponade, pericardial effusion and bradycardia are known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Investigation conclusion boston scientific has assigned an investigation conclusion code of cause not established and supporting evidence that came to this conclusion.Boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• Brand Name: FARAWAVE? NAV
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50374581
• Report Number: 2124215-2026-45145
• Device Sequence Number: 5689333
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)270506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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
• Operator of Device: Health Professional
• Device Lot Number: 0039272031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown