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

Lot Number	0039780561
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.During the preparation for a pulse field ablation procedure for the treatment of atrial fibrillation, farawave catheter was selected for use.Upon opening the sterile package, a white substance was observed on the catheter handle.Farawave catheter was replaced with a new farawave catheter to complete procedure without further issue.No patient complications were reported.
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: 50755256
• Report Number: 2124215-2026-48906
• Device Sequence Number: 15751858
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• UDI-Public: (01)00191506043193(17)270710(10)39780561
• 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,Followup
• Report Date (Section B): 09/23/2026

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: 0039780561
• 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: 08/18/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 07/10/2026
• 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