MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PFA Catheter; See H11

Medical Device Problem Codes	Off-Label Use (1494); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the atrial pacing lead of a patient dual chamber pacemaker was dislodged requiring surgical intervention to complete a lead revision.A farawave catheter was selected for use in a farapulse pulsed field ablation (pfa) procedure to treat persistent atrial fibrillation.After performing pulmonary vein isolation and posterior wall isolation in the left atrium, the physician performed a superior vena cava ablation in the right atrium with the catheter is basket shape.As the physician moved down to ablate the cavotricuspid isthmus (cti) and transitioned the catheter to flower shape, the splines of the farawave catheter snagged the atrial pacing lead of the patient non-boston scientific dual chamber pacemaker.While attempting to get away from the lead, the physician dislodged the lead.While maneuvering the farapulse catheter around the right atrium to perform a cti line ablation, the physician snagged the patients atrial pacer lead and it was pulled loose of the myocardium.The farapulse pfa procedure was completed as planned with no further issues or complications.The patient was seen later the same day for a surgical lead revision.The patient remained hospitalized for one night and was discharged the following day in stable condition.
Additional Manufacturer Narrative
Correction to section g2 report source.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of device interaction with another device and patient problem/medical problem.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the lot number was not provided; therefore, a ship history of previous lots sent to the customer were reviewed.The manufacturing batch record review confirmed that the devices met all material, assembly, and performance specifications.Labeling review: the farawave catheter ifu was reviewed and includes warnings and precautions for cardiopulmonary complications that may occur during or following catheter-based electrophysiology procedures.The procedure included svc and cti/right atrial ablation using the farawave catheter, which represents use outside the approved indication and is considered off-label.No device performance issues were identified, and no evidence suggests that labeling deficiencies contributed to the reported events.Risk review: a risk review performed for the farawave device confirmed that the events of user used incorrect product for intended use, device interaction with another device and patient problem/medical problem are known events defined in the products risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: the adverse event related to patient condition cause was selected based on the information provided within the event description.The procedure included svc and cti/right atrial ablation using the farawave catheter, which represents use outside the approved indication and is considered off-label.

• Brand Name: FARAWAVE PFA Catheter
• Common Device Name: See H11
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CENTERPOINT SYSTEMS; west valley city
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50600231
• Report Number: 2124215-2026-45609
• Device Sequence Number: 10570255
• Product Code: QZI
• UDI-Device Identifier: 00191506043216
• UDI-Public: (01)00191506043216
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: Not provided
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown