MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number	0034683215
Medical Device Problem Codes	Entrapment of Device (1212); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure to treat a persistent atrial fibrillation a farawave was selected for use.When the physician was working on the right sided veins noticed that the wire became stuck and the catheter and could not be advanced or retracted.The device was removed from the patient and replaced.The procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
Additional Manufacturer Narrative
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.

• Brand Name: FARAWAVE
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• 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: 22351515
• Report Number: 2124215-2025-42990
• Device Sequence Number: 8519861
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)260821(10)34683215
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/27/2025

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: 08/21/2026
• Device Lot Number: 0034683215
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/27/2025
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown