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

Lot Number	0039207630
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Vasospasm (2128); Heart Block (4444)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
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.
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 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 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.
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.Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of e060109 tachycardia, e2321 low blood pressure/ hypotension, e060106 heart block, e0522 vasospasm, e050301 air embolism, and a1415 air/gas.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review a risk review performed for the farawave device confirmed that the events of e060109 tachycardia, e2321 low blood pressure/ hypotension, e060106 heart block, e0522 vasospasm, e050301 air embolism, and a1415 air/gas in device are known events defined in the product risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion boston scientific has assigned an investigation conclusion code of cause not established and supporting evidence that came to this conclusion.Boston scientifics investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• 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: 50716780
• Report Number: 2124215-2026-48454
• Device Sequence Number: 9852940
• Product Code: QZI
• UDI-Device Identifier: 00191506043193
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 0039207630
• 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: 04/28/2026
• 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).; FARADRIVE Sheath (BSC).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown