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

Lot Number	0035573103
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the pulmonary vein isolation procedure, the farawave catheter was selected for use.It has been reported that after insertion of the starter wire the handle on the proximal side did not move when adjusting the tip of the catheter.It felt like the wire got stuck.No patient complications occurred.The procedure was completed using different farawave catheter.The product was received for analysis and investigation is still in progress.
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.Upon receipt at our post market quality assurance laboratory, the farawave catheter was analyzed.The catheter returned without a guidewire inserted and no abnormalities were observed.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 test performed, showing no evidence of the reported allegation.
Event or Problem Description
It was reported that during the pulmonary vein isolation procedure, the farawave catheter was selected for use.It has been reported that after insertion of the starter wire the handle on the proximal side did not move when adjusting the tip of the catheter.It felt like the wire got stuck.No patient complications occurred.The procedure was completed using different farawave catheter.The product was received for analysis.

• 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: 23895672
• Report Number: 2124215-2025-92991
• Device Sequence Number: 5331878
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270107(10)35573103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 0035573103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown