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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a redo radio frequency ablation, a farawave catheter was used.During the procedure, it was noted that the patient had atrial tachycardia (at) that was not amenable to ablation, and the patient was admitted for amiodarone loading.The patient reverted to atrial fibrillation on the evening of (b)(6) 2025 following the ablation.The patient was admitted for amiodarone loading, underwent an additional direct current cardioversion (dccv) on (b)(6) 2025, and successfully converted back to normal sinus rhythm.The patient later returned to atrial fibrillation but remained asymptomatic.The patient was discharged and continued oral amiodarone at home and is scheduled for another cardioversion after the three month follow up period.
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.

• Brand Name: FARAWAVE
• Common Device Name: SEE H11
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24003497
• Report Number: 2124215-2026-01219
• Device Sequence Number: 18688285
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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
• 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: 12/12/2025
• Initial Report FDA Received Date: 01/08/2026
• 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; Hospitalization
• Patient Sex: Unknown