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

Lot Number	0037406065
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B5: describe event or problem- updated 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 a pulse field ablation (pfa) procedure to treat atrial fibrillation, a farawave catheter was selected for use.The catheter was unable to be flushed through side flush port as the flush port was blocked.Catheter drip not functional.The original device was used to complete the procedure and no patient complications were reported.The device is expected to be returned for analysis.It was further reported that the event was discovered mid-procedure.The doctor removed the catheter after ablating in the left atrium so that they could create a post-map with a mapping catheter.It was observed that one of the pulmonary veins was still connected, so the physician needed to go back in with the farawave catheter.When the physician went to re-insert the catheter, it was noticed that the catheter wasn't dripping.The physician opened the flush, but nothing was coming out.Flush port was blocked.The rep is unsure if this issue was present upon opening the packaging.After the issue was discovered, the catheter was replaced and they completed the procedure with a new catheter.
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 a pulse field ablation (pfa) procedure to treat atrial fibrillation, a farawave catheter was selected for use.The catheter was unable to be flushed through side flush port as the flush port was blocked.Catheter drip not functional.The original device was used to complete the procedure and no patient complications were reported.The device is expected to be returned 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: 23809688
• Report Number: 2124215-2025-90919
• Device Sequence Number: 15777287
• Product Code: QZI
• UDI-Device Identifier: 00191506043155
• UDI-Public: (01)00191506043155(17)270909(10)37406065
• 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
• Report Date (Section B): 01/28/2026

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: 0037406065
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 09/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown