MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; NO MATCH

Lot Number	0033443458
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulsed field ablation (pfa) procedure to treat atrial fibrillation, a farawave catheter was selected for use.During preparation, it was noted that catheter slider was difficult to maneuver.The physician exercised the slider knob several times.The issue resolved, and the catheter was brought to the table to be inserted.When hooking catheter up to flush, it was then noted that the side flush port was broken and fluid leaking out of the side flush port.The catheter was replaced, and procedure was completed with no patient complications reported.The catheter is expected to be returned for analysis.
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.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Device technical analysis: upon device return and inspection, it was observed that the strain relief was detached from the luer.A guidewire was inserted into the catheter, and the catheter was deployed to basket and flower configurations successfully.Microscopic analysis of the catheter was performed and with the help of an ultraviolet (uv) light, separation between the strain relief/luer could be seen.The reported flush port damage and leak was confirmed, however, the reported difficulty deploying the catheter could not be confirmed via analysis.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.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.Risk review a risk review performed for the farawave device confirmed that the events of luer damage and leak are known event defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the farawave device is acceptable.Investigation conclusion: based on the available information, boston scientifics investigation determined the flush port damage and leak.Investigation found it possible that the cause of the event may be due to the manufacturing process.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
During a pulsed field ablation (pfa) procedure to treat atrial fibrillation, a farawave catheter was selected for use.During preparation, it was noted that catheter slider was difficult to maneuver.The physician exercised the slider knob several times.The issue resolved, and the catheter was brought to the table to be inserted.When hooking catheter up to flush, it was then noted that the side flush port was broken and fluid leaking out of the side flush port.The catheter was replaced, and procedure was completed with no patient complications reported.

• Brand Name: FARAWAVE
• Common Device Name: NO MATCH
• 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: 23933524
• Report Number: 2124215-2025-93909
• Device Sequence Number: 14855677
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)260218(10)33443458
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/06/2026

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 Expiration Date: 02/18/2026
• Device Lot Number: 0033443458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown