MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004PF61M401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Pericarditis (4448)
Date of Event	07/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient experienced suppression and suspected pericarditis.During a pulsed field ablation (pfa) procedure a farastar pfa generator nam was selected for use.This was a "research case" that lasted 3.5 hours where 56 farawave ablations were delivered to patient.It was reported that p-wave suppression and suspected pericarditis occurred.Opal was not involved as this was a carto mapping case.Case was completed there were no remarks from physician no additional information available.
Additional Manufacturer Narrative
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because insert reason (device was discarded, etc.).Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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.
Event or Problem Description
It was reported that a patient experienced suppression and suspected pericarditis.During a pulsed field ablation (pfa) procedure a farastar pfa generator nam was selected for use.This was a "research case" that lasted 3.5 hours.56 farawave ablations were delivered to patient.16 l sup, 16 l inf, 12 r sup and 12 r inf.Opal was not involved as this was a carto mapping case.Case was completed there were no remarks from dr.No more information available.

• Brand Name: FARAWAVE
• Common Device Name: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22666128
• Report Number: 2124215-2025-52079
• Device Sequence Number: 3702407
• Product Code: QZI
• UDI-Device Identifier: 00191506042882
• UDI-Public: (01)00191506042882(11)240828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: M004PF61M401
• Device Catalogue Number: M004PF61M401
• Device Lot Number: 0105858849
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 08/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown