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

Lot Number	0038327781
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vomiting (2144); Discomfort (2330)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.When any further relevant information is obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.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.
Event or Problem Description
It was reported that the patient experienced stomach discomfort and vomited once after the procedure.After a pulse field ablation (pfa) procedure using a farawave catheter the patient experienced stomach discomfort and vomited gastric contents once.The patient was administered medication which resolved the complications.
Event or Problem Description
It was reported that the patient experienced stomach discomfort and vomited once after the procedure.After a pulse field ablation (pfa) procedure using a farawave catheter the patient experienced stomach discomfort and vomited gastric contents once.The patient was administered medication which resolved the complications.
Additional Manufacturer Narrative
Investigation summary: based on the available information, although no product has been returned despite three requests for its return, we have determined that the vomiting and discomfort are known inherent risks with use of this product.Device technical analysis: boston scientific has made three attempts to retrieve the device however no response was received; the device is not expected to be returned; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use confirmed that vomiting and discomfort are addressed as potential procedural complications when using the farawave catheter.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the farawave catheter device confirmed that the event of vomiting and discomfort is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the farawave catheter device is acceptable.Investigation conclusion: based on the information provided, the reported event of vomiting and discomfort are known inherent risks of the farawave catheter.As stated by the instructions for use, "potential adverse events associated with use of the farawave catheter includes, but are not limited to: pain or discomfort, procedural related side effects." there were no indications that the device was used outside the bounds of labeled/indicated use or evidence of a product performance related issue.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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.
Event or Problem Description
It was reported that the patient experienced stomach discomfort and vomited once after the procedure.After a pulse field ablation (pfa) procedure using a farawave catheter the patient experienced stomach discomfort and vomited gastric contents once.The patient was administered medication which resolved the complications.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes the reported stomach discomfort and vomiting were adverse events related to the procedure.The device was not received for analysis despite three requests for its return.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: boston scientific has made three attempts to retrieve the device however no response was received; the device is not expected to be returned; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use confirmed that vomiting and discomfort are addressed as potential procedural complications when using the farawave catheter.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the farawave catheter device confirmed that the event of vomiting and discomfort is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the farawave catheter device is acceptable.Investigation conclusion: based on all the available information, boston scientific has assigned an investigation conclusion code of adverse event related to procedure to the reported event.The patient experienced stomach discomfort and a single episode of vomiting following the ablation procedure.The event occurred on the same day as the procedure, was assessed as related to surgery, and the relationship to the study procedure was considered probable.Medication was administered, after which the reported discomfort and vomiting resolved without hospitalization or additional intervention.There were no indications that the device was used outside the bounds of labeled/indicated use or evidence of a product performance related issue.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.Correction to the initial mdr in block g2.Additional information added to blocks a4 and d4.

• 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: 25048013
• Report Number: 2124215-2026-23494
• Device Sequence Number: 9921378
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)270115(10)38327781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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?: No
• Operator of Device: Health Professional
• Device Lot Number: 0038327781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 08/24/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/09/2026; 09/15/2026
• Date Device Manufactured: 01/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 167 LB