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

Lot Number	0037519515
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event- estimated as 01 january 2026 as the date of event is unknown other than occurred in january 2026.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.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure using a farawave catheter, the catheter would not flush with the pump.No patient harm occurred.Another catheter was opened and used to complete the case.Mdr report: 0700100000-2026-8011.

• 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: 24675060
• Report Number: 2124215-2026-16045
• Device Sequence Number: 10144954
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270923(10)37519515
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

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: 0037519515
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown