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

Lot Number	0035990713
Medical Device Problem Codes	Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/03/2025
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 the catheter was difficult to position at the left pulmonary veins and exhibited a spline inversion, and the patient experienced pericardial effusion and hypotension.During a pulse field ablation (pfa) procedure a farawave catheter was used.During transeptal puncture (tsp), the versacross wire kept sliding posterior.The physician repositioned a few times and then decided to use a posterior stick.The physician was unable to advance the faradrive sheath across the septum, so the versacross wire was pulled back to reposition and go transseptal again.During the repositioning, the scrub tech pushed the foot pedal for radio frequency delivery for transseptal.It was unconfirmed where the wire was positioned at this time.Bubbles were noted in the left atrium (la) and the wire was advanced into the left atrium (la).The intracardiac echocardiography (ice) catheter was advanced to the la, and then the farardrive sheath was advanced there with the farawave catheter inside.The physician felt it was too tight to move the sheath, so the ice catheter was removed from the la and positioned in the right atrium (ra).The farawave catheter was then advanced to the left pulmonary veins, but the physician struggled to position it there and moved to the right pulmonary veins.The catheter array was opened to the basket shape, but it had a spline inversion.The catheter marker was not out of the sheath and the splines were close to sheath.The catheter was removed from the patient to fix the inversion manually.The anesthesiologist checked the blood pressure, which was found to be lower.An effusion was noted on ice.The effusion was growing larger, so it was decided to perform a pericardiocentesis.The patient was stable after 460 ml of blood was removed from the pericardium.The procedure was aborted and the patient was taken to the intensive care unit (icu).The activated clotting time (act) was 354 during transseptal.In the physician's opinion, it was a tough transeptal puncture due to patient anatomy.No ablation deliveries were made with the farawave catheter prior to procedure cancellation.The patient was still in the icu the following day but was released from the hospital a few days after the procedure.The device is not expected to be returned for analysis (disposed).

• 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: 22333958
• Report Number: 2124215-2025-42230
• Device Sequence Number: 9126552
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270304(10)35990713
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/26/2025

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: 0035990713
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 03/04/2025
• 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; Hospitalization; Life Threatening
• Patient Sex: Female