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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a death occurred.A farawave catheter was selected for use during pulsed field ablation.It has been mentioned that the patient died.The cause of death is unknown.No patient complications occurred during the procedure.Per physician, the boston scientific device or procedure did not cause or contribute to the patient's death.
Event or Problem Description
It was reported that a death occurred.A farawave catheter was selected for use during pulsed field ablation performed on (b)(6)2025.It has been mentioned that the patient died on (b)(6) 2026.The cause of death is unknown.No patient complications occurred during the procedure.Per physician, the boston scientific device or procedure did not cause or contribute to the patient's death.
Additional Manufacturer Narrative
D2a common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unavailable.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Additional Manufacturer Narrative
D2a common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unavailable.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.This supplemental report is being submitted with an update to sections: b2: date of death, b5: describe event or problem & h6: patient codes.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported event of death.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history review: the ship history review could not be completed because the required information was unavailable.Therefore, the device history record (dhr) review could not be performed.Risk review: a risk review performed for the farawave device confirmed that the event of death is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: 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.Investigation conclusion: boston scientific has assigned an investigation conclusion code of cause not established based on the information provided within the event description.The reported death occurred more than 90 days following the ablation procedure.Boston scientific determines that deaths occurring beyond 90 days may generally be considered unrelated to the device or procedure when no specific allegation, clinical finding, or recognized delayed complication supports a relationship.No patient complications were reported during the procedure, the physician indicated that the boston scientific device or procedure did not cause or contribute to the patient's death, and no device malfunction or product performance issue was identified.However, the circumstances surrounding the death and the official cause of death remain unknown.Therefore, although the available information does not support a relationship between the reported death and the farawave device or procedure, there is insufficient information to establish the specific cause of death.

• Brand Name: FARAWAVE Pulsed Field Ablation Catheter
• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50223090
• Report Number: 2124215-2026-43180
• Device Sequence Number: 5482183
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 311 LB