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

Lot Number	0039159150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pericardial effusion.During a procedure to treat atrial fibrillation and a watchman implant a farawave was selected for use.A trivial effusion around the right ventricle (rv) was noted on intracardiac echocardiography (ice) by the physician prior to start of the radiofrequency (rf) ablation with a non-boston scientific device.A cavotricuspid isthmus (cti) ablation was performed using a non-boston scientific rf catheter prior to the transeptal, prior to the insertion of a faradrive sheath and farawave catheter for the pulse field ablation.Physician stated to have heard a steam pop with the rf ablation.Cti ablation was completed with non-boston scientific rf catheter.The physician exchanged the non-boston scientific sheath for another non-boston scientific device and performed a transeptal with a non-boston scientific device using fluoroscopy and ice guidance.A non-boston scientific was exchanged for the faradrive sheath over a 230cm bsc starter rosen j wire.The wire could be visualized on ice and fluoroscopy position in the common left pulmonary vein during sheath exchange.The farawave catheter was advanced over the wire into the left common vein, basket and flower applications were performed.The physician used ice to check for effusion and noted the trivial effusion around rv prior to any therapy delivery had increased.The effusion was noted during procedure when physician pulled ice catheter back into right atrium and did an ice sweep to observe effusion noted preablation.Non-boston scientific rf catheter was outside of the body when the issue occurred.The physician completed the pvi successfully using the farawave catheter while monitoring the pericardial effusion with ice.No perforation location was confirmed, no saved images available.No resistance was felt while maneuvering the catheter.Effusion occurred around the right ventricle, trivial effusion was seen on ice per physician prior to any ablation therapy or transeptal.Farawave was in the left atrium when the worsening of the effusion was discovered.Rf ablation had been completed, and the farawave had only been used for delivery of 4 baskets and 4 flowers before the worsened effusion was observed.Dwell time is unknown.Unknown duration of ablation time when complication was observed.Farawave in body/la dwell time was 30 minutes.Post pulse field ablation (pfa), the physician performed a pericardial effusion drainage and removed approximately 150ml of blood, the drainage tube was left in place over night and the patient was transferred to the intensive care unit (icu).The physician stated no additional drainage was recorded and the tube was removed next day post procedure and patient was discharged fully recovered.The physician is attributing the change in effusion to the steam pop associated with the non-boston scientific rf catheter.The scheduled watchman portion of the procedure was canceled due to the effusion with the intent to reschedule as a standalone procedure at a later date.The patient is expected to make a full recovery.
Additional Manufacturer Narrative
D2a: common device name is percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation; reported here as common device name exceeded character limit for designated field.Patient information was not available at the facility.

• 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: 50754467
• Report Number: 2124215-2026-48889
• Device Sequence Number: 13071810
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• UDI-Public: (01)00191506043216(17)270423(10)39159150
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 0039159150
• 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: 08/21/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown