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

Lot Number	0039283194
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Blocked Connection (2888); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire stuck, guidewire kink, guidewire lumen obstruction and deployment issue occurred.During an atrial fibrillation ablation procedure, a farawave catheter was selected for use.Multiple attempts to remove the guidewire from the catheter were unsuccessful.Troubleshooting efforts, including advancing and backloading the guidewire, were performed; however, resistance was encountered and the guidewire lumen appeared to be obstructed.Farawave catheter deployment issue was also observed during use.Farawave catheter was subsequently removed from the patient.Upon removal, the guidewire was noted to be kinked.Farawave catheter was replaced with a new farawave catheter to complete the procedure without further issue.No patient complications were reported.It was further reported the splines were reported to be out of plane when the deployment issue was noted.
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.

• Brand Name: FARAWAVE? NAV
• 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: 50952324
• Report Number: 2124215-2026-52118
• Device Sequence Number: 18529703
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/30/2026

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: 0039283194
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown