MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE? NAV; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Lot Number	0038835599
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pulse field ablation (pfa) procedure was being performed using a farawave catheter and a faradrive steerable sheath clear.After the farawave catheter was inserted into the faradrive sheath, air aspiration was performed within the sheath.Despite repeated attempts, air continued to be aspirated from the catheter tip.Following sheath removal, the patient experienced st-segment elevation, hypotension, and atrioventricular (av) block.Noradrenaline was administered, and coronary angiography (cag) was performed.Vasospasm was observed during cag, and nitroglycerin was administered.Although vasospasm occurred, the relationship between the event and the device could not be determined.After the patient's condition stabilized, cag reportedly demonstrated air ingress.The procedure was resumed, and both the farawave catheter and faradrive steerable sheath clear were replaced with a second farawave catheter and a second faradrive steerable sheath clear.Air aspiration was performed again; however, the same issue of continued air aspiration was reproduced.At the physician's discretion, the farawave catheter was removed and replaced with a non-boston scientific pfa catheter in order to continue the procedure.Pulmonary vein isolation (pvi) was subsequently completed, and the procedure was finished successfully.The physician reported that because the issue persisted despite replacement of both the catheter and sheath, the event was not believed to be product related.The patient remained stable following the procedure and was discharged from the hospital.
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.

• Brand Name: FARAWAVE? NAV
• Common Device Name: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
• 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 ; +1(651)440-0979
• MDR Report Key: 50716940
• Report Number: 2124215-2026-48459
• Device Sequence Number: 18800725
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• UDI-Public: (01)00191506043193(17)270314(10)38835599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 0038835599
• 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: 08/21/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 03/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARADRIVE Sheath (BSC)
• Patient Sex: Unknown