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

Lot Number	0036565577
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Myocardial Infarction (1969); Vasoconstriction (2126); Ventricular Fibrillation (2130); Heart Block (4444)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced an arrhythmia, myocardial infarction, ischemia, st segment elevation, cardiac arrest, heart block and vasospasm.It was reported that farawave was selected for use during a af ablation.Prior to procedure start patient was having to be hemodynamically supported due to hypotension (ef 35-40%).Underwent procedure at physicians' discretion.Ablated left superior pulmonary vein (lspv), left inferior pulmonary vein (lipv), right superior pulmonary vein (rspv) following optiwave workflow.Right inferior pulmonary vein (ripv) was engaged and four flowers were done, physician was moving into basket to finish the last four lesions.At the time of the fourth flower, physician noticed st segment elevation in inferior leads and heart rate increase.Ruled out air emboli with angiography.Interventional cardiology (ic) paged and started left heart catheterization (lhc).During lhc, patient went into pulseless electrical activity (pea) and compressions were started following acls protocols along with pharmacological interventions.Lhc resumed, paused compressions to get a contrast shot of the right coronary artery (rca), confirmed rca vasospasm.Patient went into ventricular fibrillation and was shocked once.Ic team then placed an non-boston scientific heart pump device to support hemodynamics, non-boston scientific sheath and farawave catheter removed from left atrium at this time.Lhc resumed, and patient was given intracoronary nitroglycerin.Vasospasm resolved.Ic team then placed a swan for a right heart catheterization (rhc).At the time of this writing, patient currently hemodynamically stable in procedure room on heart pump and vasopressors (neosynephrine, epinephrine, nitroglycerin and others - not disclosed).The patient was admitted to icu following procedure end due to this complication.The patient had recovered and was discharged from the hospital.The product is not expected to return, as it was retained by the facility.
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.

• 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: 23488314
• Report Number: 2124215-2025-80251
• Device Sequence Number: 10499676
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270520(10)36565577
• 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
• Report Date (Section B): 11/06/2025

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: 0036565577
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/06/2025
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male