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

Lot Number	0035710335
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during preparation for a pulse field ablation procedure to treat atrial fibrillation, a farawave nav catheter was selected for use.It was noted that the flush port was warped.This damage was noticed upon opening the device packaging.The catheter was replaced, and the procedure was completed successfully without patient complications.The catheter is expected to be returned for analysis.
Event or Problem Description
It was reported that during preparation for a pulse field ablation procedure to treat atrial fibrillation, a farawave nav catheter was selected for use.It was noted that the flush port was warped.This damage was noticed upon opening the device packaging.The catheter was replaced, and the procedure was completed successfully without patient complications.The catheter was not returned for analysis.
Additional Manufacturer Narrative
Media review: an image was reviewed by a boston scientific quality engineer.In the image, it is possible to observe that the flush port was warped.The reported event was confirmed; however, boston scientific was unable to establish a clear conclusion about the cause of the reported event.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: 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: 23515746
• Report Number: 2124215-2025-81626
• Device Sequence Number: 21238104
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)260126(10)35710335
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/12/2025

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: 01/26/2026
• Device Lot Number: 0035710335
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 01/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown