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

Lot Number	0038887949
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Pericarditis (4448); Renal Impairment (4499); High White Blood Cell Count (4594)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pericarditis, chest pain, abnormal renal laboratory results, and abnormal hematology results requiring medication.A farawave and farapoint pulsed field ablation catheters were selected for use during a pulsed field ablation (pfa) procedure.Following the procedure, the patient developed left-sided pleuritic chest pain radiating to the lateral chest with deep inspiration and was diagnosed with pericarditis.The patient had no history of similar pain and reported no shortness of breath, palpitations, or lightheadedness.No electrocardiogram (ecg) changes were observed.Diagnostic assessment included a chest x-ray with inspiratory and expiratory views, which did not demonstrate pneumothorax.To treat the pericarditis, the patient received paracetamol on (b)(6) 2026 and colchicine on (b)(6) 2026.Laboratory testing performed on (b)(6) 2026 demonstrated elevated creatinine (118 umol/l), elevated urea (8.4 mmol/l), elevated white blood cell count (13.1 x 10^9/l), elevated neutrophils (12.57 x 10^9/l), lymphocytes of 0.88 x 10^9/l, and red blood cell count (4.47 x 10^12/l).These findings were indicative of leukocytosis with neutrophilia and lymphopenia.Laboratory testing performed on (b)(6) 2026 showed creatinine of 111 umol/l, elevated urea (13.7 mmol/l), decreased albumin (31.9 g/l), elevated white blood cell count (12.7 x 10^9/l), elevated neutrophils (10.58 x 10^9/l), lymphocytes of 0.92 x 10^9/l, elevated monocytes (1.11 x 10^9/l), and red blood cell count (4.05 x 10^12/l).The pericarditis and chest pain events resolved on (b)(6) 2026.
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? NAV
• 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: 50809796
• Report Number: 2124215-2026-49795
• Device Sequence Number: 8644431
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• UDI-Public: (01)00191506043193(17)270321(10)38887949
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 0038887949
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARAPOINT Ablation Catheter (BSC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 204 LB