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

Lot Number	0039299777
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that for a pulse field ablation (pfa) procedure to treat a persistent atrial fibrillation a farawave ablation catheter was selected for use.The catheter was prepared with no issues noted.No spline bunching, fluid leakage, or guidewire resistance was observed during preparation.After six applications were delivered in basket configuration within the left superior pulmonary vein, the physician observed excessive fluid on the patient drape and catheter handle.No air was observed entering the patient.The catheter was removed from the patient, and upon inverting the handle, fluid was observed exiting from the orange slider switch.The catheter was replaced and the procedure was successfully completed using the replacement device.No patient complications occurred, and the patient remained stable throughout the procedure.
Additional Manufacturer Narrative
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.Investigation summary: with all the available information, boston scientific concludes the reported leak was confirmed.Laboratory analysis of the returned farawave found that during the flow testing, a leak was confirmed at the flush port region.Subsequent dissection and microscopy revealed that the flush port was damaged and separated from the flush tubing, which caused the leak.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: upon device return and inspection, no outer abnormalities were observed on the main catheter body.Functional testing was preformed and a guidewire was successfully inserted through the catheter.Deployment was tested multiple times, and deployment to basket and flower was functional with no unusual resistance noted.Flow test found that flushing through the irrigation port was tested.During irrigation, a leak was observed in the luer of the catheter.The catheter was dissected for further inspection of the leak source.It was revealed that the flush port was damaged and partially separated from the flush tubing, which created a leak consistent.Under microscope and with uv light, separation and discontinuity between the flush port and the flush tubing were observed.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Investigation conclusion: based on all the available information, the cause of the reported leak was likely attributed to the device design.During the flow testing, a leak was confirmed at the flush port region.Subsequent dissection and microscopy revealed that the flush port was damaged and separated from the flush tubing, which caused the leak.

• 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: 50410424
• Report Number: 2124215-2026-45349
• Device Sequence Number: 13375744
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)280509(10)39299777
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 0039299777
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2026
• 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
• Patient Sex: Unknown