MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number	0036565579
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	07/15/2025
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 hypotension and a pericardial effusion.During a pulsed field ablation (pfa) procedure a farawave was selected for use.After the procedure was completed, it was noticed that the patient's blood pressured dropped.The physician checked the intracardiac echocardiography (ice) and noticed a pericardial effusion.The patient was taken to the operation room to perform a pericardial window.The patient recovered successfully from the event.
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.B5 describe event or problem updated with new information obtained.
Event or Problem Description
It was reported that a patient experienced hypotension and a pericardial effusion.During a pulsed field ablation (pfa) procedure a farawave was selected for use.After the procedure was completed, it was noticed that the patient's blood pressured dropped.The physician checked the intracardiac echocardiography (ice) and noticed a pericardial effusion.The patient was taken to the operation room to perform a pericardial window.The patient recovered successfully from the event.It was further reported that no issues were found moving the guidewire during the procedure.Effusion was discovered post-procedure and the pericardiocentesis solved the issue.Patient had recovered and was discharged successfully.

• Brand Name: FARAWAVE
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• 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 ; 6514400979
• MDR Report Key: 22751802
• Report Number: 2124215-2025-55416
• Device Sequence Number: 21011544
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270520(10)36565579
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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 Lot Number: 0036565579
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Race: White