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

Lot Number	0037424616
Medical Device Problem Codes	Contamination (1120); Failure to Deliver Energy (1211); Off-Label Use (1494); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
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.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 an ablation procedure one farawave catheter was selected for being used, catheter initially worked and delivered six applications.Midway through the procedure, energy delivery stopped without any opal error message.Replacing the catheter resolved the issue.Upon inspection, the original catheter had unusual white markings on its handle, though packaging was sterile and not expired.It was also indicated that the packaging was damaged.No patient complications occurred.The device is not expected to return for laboratory analysis since it was disposed.
Event or Problem Description
It was reported that during an ablation procedure one farawave catheter was selected for being used, catheter initially worked and delivered six applications.Midway through the procedure, energy delivery stopped without any opal error message.Replacing the catheter resolved the issue.Upon inspection, the original catheter had unusual white markings on its handle, though packaging was sterile and not expired.It was also indicated that the packaging was damaged.No patient complications occurred.The device is not expected to return for laboratory analysis since it was disposed.
Additional Manufacturer Narrative
Correction to initial mdr in block h6: device codes.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.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.
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.The device was not returned for analysis; however, images of the catheter were provided to investigators which confirmed the presence of the white material on the catheter handle.The appearance of the white material is consistent with adhesive used during the manufacturing process.The presence of this excess material is considered to be a quality control deficency.
Event or Problem Description
It was reported that during an ablation procedure one farawave catheter was selected for being used, catheter initially worked and delivered six applications.Midway through the procedure, energy delivery stopped without any opal error message.Replacing the catheter resolved the issue.Upon inspection, the original catheter had unusual white markings on its handle, though packaging was sterile and not expired.It was also indicated that the packaging was damaged.No patient complications occurred.The device is not expected to return for laboratory analysis since it was disposed.

• Brand Name: FARAWAVE NAV PFA CATHETER
• 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: 23873582
• Report Number: 2124215-2025-92513
• Device Sequence Number: 19968220
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)260910(10)37424616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 02/20/2026

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 Expiration Date: 09/10/2026
• Device Lot Number: 0037424616
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 01/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/20/2026
• Date Device Manufactured: 09/10/2025
• 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