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

Model Number	M004PF41M412
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Syncope/Fainting (4411); Asystole (4442)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device return status is not known.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.Detailed product information was not provided to bsc and was not able to be obtained.Because the lot number is unknown, we are unable to provide the full unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a patient experienced asystole.While performing a farawave nav case on a patient, the patient was treated for atrial fibrillation and a right sided cavo-tricuspid isthmus (cti) line with a farawave nav catheter was performed prior to crossing over into left atrium, which cti ablation is considered off label use of the farawave catheter.Four pfa deliveries occurred in the right atrium for cti line for flutter then 2 deliveries occurred in the left superior pulmonary vein (lspv) in flower deployment configuration.At this point, the patient went asystole and chest compressions were performed and epinephrine (caused patient blood pressure to elevate) and then nitro was administered (causing patient to bottom out pressure-wise).The code lasted 15-20 seconds.It is suspected that the physician hit a ganglionated plexi, which caused patient to vagal down and go asystole for the 15-20 seconds.Rhythm recovered after this period.The physician was concerned for a possible effusion and brought the patient in echo and it was confirmed there was no effusion.Since the patient blood pressure was unstable, therapy was aborted at that time.The patient was in stable condition when removed from table.The patient was kept overnight for observation and was discharged the following day with no residual effects from the prior day procedure.
Event or Problem Description
It was reported that a patient experienced asystole.While performing a farawave nav case on a patient, the patient was treated for atrial fibrillation and a right sided cavo-tricuspid isthmus (cti) line with a farawave nav catheter was performed prior to crossing over into left atrium, which cti ablation is considered off label use of the farawave catheter.Four pfa deliveries occurred in the right atrium for cti line for flutter then 2 deliveries occurred in the left superior pulmonary vein (lspv) in flower deployment configuration.At this point, the patient went asystole and chest compressions were performed and epinephrine (caused patient blood pressure to elevate) and then nitro was administered (causing patient to bottom out pressure-wise).The code lasted 15-20 seconds.It is suspected that the physician hit a ganglionated plexi, which caused patient to vagal down and go asystole for the 15-20 seconds.Rhythm recovered after this period.The physician was concerned for a possible effusion and brought the patient in echo and it was confirmed there was no effusion.Since the patient blood pressure was unstable, therapy was aborted at that time.The patient was in stable condition when removed from table.The patient was kept overnight for observation and was discharged the following day with no residual effects from the prior day procedure.It was further reported that the catheter was discarded immediately after the case and was not sent back for analysis.It was believed that the event was not due to the catheter by the technical department when the rep called to report the incident.
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.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc and was not able to be obtained.Because the lot number is unknown, we are unable to provide the full unique identifier (udi) and other specific product information.Based on the analysis, it was indicated that the device was used to treat a cavotricuspid isthmus (cti), which is off label use of the device as the farawave catheter is indicated for the ablation of the pulmonary veins to treat paroxysmal atrial fibrillation.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23594512
• Report Number: 2124215-2025-84497
• Device Sequence Number: 9641038
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M004PF41M412
• Device Catalogue Number: M004PF41M412
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FARADRIVE SHEATH; FARADRIVE SHEATH; ROSEN GUIDEWIRE; ROSEN GUIDEWIRE; VERACROSS CONNECT; VERACROSS CONNECT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown