MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE?; See H11

Lot Number	0036023315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After a pulse field ablation (pfa) procedure for the treatment of paroxysmal atrial fibrillation using a farawave catheter, the patient experienced a worsening of a pre-existing atrial fibrillation.Subsequently an rf ablation (re-ablation) was performed on the pulmonary vein (ripv), superior vena cava, and tricuspid-inferior vena cava isthmus.Following the procedure, the patient's condition improved.
Event or Problem Description
After a pulse field ablation (pfa) procedure for the treatment of paroxysmal atrial fibrillation using a farawave catheter, the patient experienced a worsening of a pre-existing atrial fibrillation.Subsequently an rf ablation (re-ablation) was performed on the pulmonary vein (ripv), superior vena cava, and tricuspid-inferior vena cava isthmus.Following the procedure, the patient's condition improved.
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.
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.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of an atrial fibrillation.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 atrial fibrillation is a known event defined in the products 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 adverse event related to patient condition and supporting evidence that came to this conclusion.The patient had a documented pre-existing history of atrial fibrillation, and the reported event was identified as worsening of this pre-existing condition.The physician assessed the event as unrelated to the farawave device, and no evidence was identified to support a device- or procedure-related mechanism.Therefore, the reported atrial fibrillation is considered most consistent with the patients pre-existing condition.Boston scientifics 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?
• Common Device Name: See H11
• 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: 50602340
• Report Number: 2124215-2026-47103
• Device Sequence Number: 13439572
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)270308(10)36023315
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 0036023315
• 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: 09/28/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 03/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown