MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Lot Number	0039159150
Medical Device Problem Codes	Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation, a farawave ablation catheter was selected for use.During preparation, it was noted that the wire had a slight resistance when pulling back into the catheter.After an additional inspection, a small fragmentation was noticed at the distal tip of the catheter.The catheter was replaced and procedure was completed with no patient complications.
Event or Problem Description
During an atrial fibrillation ablation, a farawave ablation catheter was selected for use.During preparation, it was noted that the wire had a slight resistance when pulling back into the catheter.After an additional inspection, a small fragmentation was noticed at the distal tip of the catheter.The catheter was replaced and procedure was completed with no patient complications.
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.
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.Device technical analysis: during product analysis the device passed all tests performed, showing no evidence of the reported failure.Additionally, no damage or defects were observed during the analysis.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.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 (ifu).Risk review: a risk review performed for the fawave device confirmed that the event of damage and difficult to load wire are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific has assigned an investigation conclusion code of no problem detected for the reported allegations as the allegations were unable to be confirmed, and no issues were observed during the analysis.A guidewire was successfully inserted through the catheter.Deployment was tested multiple times, and the device was deployed to basket and flower position with no unusual resistance noted.The device passed all tests performed, showing no evidence of the reported failure.Additionally, no damage or defects were observed during the analysis.

• Brand Name: FARAWAVE
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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: 50565498
• Report Number: 2124215-2026-46850
• Device Sequence Number: 21355218
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,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: 0039159150
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown