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

Lot Number	0039191762
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a pulse field ablation (pfa) procedure for the treatment of atrial fibrillation (af), a farawave catheter was selected for use.Pulmonary vein isolation and posterior wall ablation were completed in the left atrium.The patient was then cardioverted (dccv) to normal sinus rhythm (nsr) to allow pacing in the right atrium for assessment of conduction block across a previously created cavotricuspid isthmus (cti) line.The patient subsequently returned to af and required a second dccv to allow further cti assessment.The physician determined that the cti line from the previous procedure appeared blocked.The patient again returned to af, and the physician proceeded with superior vena cava (svc) ablation, delivering four basket applications and four flower applications.Following svc isolation, the patient was cardioverted again and was noted to be bradycardic with a junctional escape rhythm of 20 bpm.Pacing was performed through the coronary sinus (cs) catheter at cycle lengths of 600 ms, 1000 ms, and 1200 ms.Glycopyrrolate 0.2 mg was administered, after which the patient's intrinsic rhythm exceeded the paced rate, and pacing was discontinued.After awakening from general anesthesia, the patient's rhythm alternated between junctional rhythm and sinus rhythm.The patient remained stable throughout the episode with pacing support and after pacing was discontinued.The patient was transferred to the recovery area, where sinus node function recovered.The patient recovered fully without additional hospitalization.The physician believed the adverse event was related to the procedure and attributed it to sinus node stunning following pfa energy delivery during svc isolation.
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: 50870458
• Report Number: 2124215-2026-50693
• Device Sequence Number: 9224096
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• UDI-Public: (01)00191506043216(17)270427(10)39191762
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 09/23/2026

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: 0039191762
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/27/2026
• 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
• Patient Sex: Unknown