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

Lot Number	0036025798
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that atrial fibrillation occurred.It was reported that a farawave catheter was selected for a pulse field ablation (pfa) to treat a paroxysmal atrial fibrillation (paf).Post procedure, atrial fibrillation occurred.Electrical cardioversion was performed, and the patient's condition improved.The event was reported to be related to an exacerbation of the patient's pre-existing atrial fibrillation (af).Product return is not expected as it was discarded.It was informed that the patient's condition has improved.
Event or Problem Description
It was reported that atrial fibrillation occurred.It was reported that a farawave catheter was selected for a pulse field ablation (pfa) to treat a paroxysmal atrial fibrillation (paf).Post procedure, atrial fibrillation occurred.Electrical cardioversion was performed, and the patient's condition improved.The event was reported to be related to an exacerbation of the patient's pre-existing atrial fibrillation (af).Product return is not expected as it was discarded.It was informed that the patient's condition has improved.
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 atrial fibrillation.The device was discarded; therefore, a technical analysis of the complaint device could not be completed.Device history record (dhr) 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.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).Risk review: a risk review performed for farawave device confirmed atrial fibrillation is a known event defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.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 pre-existing paroxysmal atrial fibrillation, and the post-procedural atrial fibrillation was reported to be related to an exacerbation of the patient pre-existing condition.Electrical cardioversion was performed, after which the patients condition improved.There is no evidence of device malfunction or unintended device performance, and based on the available information, a definitive cause for the event could not be established.
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.

• 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: 50156522
• Report Number: 2124215-2026-42121
• Device Sequence Number: 10708631
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)270310(10)36025798
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 0036025798
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown
• Patient Weight: 116 LB