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

Lot Number	0036130399
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter was used off label and months later the patient experienced worsening atrial fibrillation requiring a re-ablation procedure.During a pulse field ablation (pfa) procedure to treat non-paroxysmal atrial fibrillation a farawave catheter was used.Ablation was performed on the left superior pulmonary vein (lspv), left carina, right superior pulmonary vein (rspv), cardiac floor, cardiac roof, the left atrial posterior wall (lapw), and the right atrium (ra) septal.Use of the catheter to treat non-paroxysmal atrial fibrillation and to ablate the left carina, cardiac floor and roof, the lapw, and the ra septal constituted off label use of the device.The procedure was completed successfully with no patient complications at the time.Almost four months after the procedure, on 2-october-2025, the patient experienced atrial fibrillation that was attributed to the worsening of the patient's pre-existing atrial fibrillation.It was noted that the patient was hospitalized, though the reason for and the duration of the hospitalization is unknown.A re-ablation procedure using pfa was performed on the superior vena cava, and the patient's condition improved in the time after this re-ablation procedure.It was further reported that the patients condition was improving after the re-ablation procedure.
Event or Problem Description
It was reported that the catheter was used off label and months later the patient experienced worsening atrial fibrillation requiring a re-ablation procedure.During a pulse field ablation (pfa) procedure to treat non-paroxysmal atrial fibrillation a farawave catheter was used.Ablation was performed on the left superior pulmonary vein (lspv), left carina, right superior pulmonary vein (rspv), cardiac floor, cardiac roof, the left atrial posterior wall (lapw), and the right atrium (ra) septal.Use of the catheter to treat non-paroxysmal atrial fibrillation and to ablate the left carina, cardiac floor and roof, the lapw, and the ra septal constituted off label use of the device.The procedure was completed successfully with no patient complications at the time.Almost four months after the procedure, on 2-october-2025, the patient experienced atrial fibrillation that was attributed to the worsening of the patient's pre-existing atrial fibrillation.It was noted that the patient was hospitalized, though the reason for and the duration of the hospitalization is unknown.A re-ablation procedure using pfa was performed on the superior vena cava, and the patient's condition improved in the time after this re-ablation procedure.
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 atrial fibrillation and user used incorrect product for intended use.The device was discarded, a technical analysis of the complaint device could not be completed.Device history record (dhr) 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 evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The procedure included the farawave catheter used to perform ablation outside the indicated lesion set is 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 farawave device confirmed atrial fibrillation and user used incorrect product for intended use are known event 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 adverse event related to patient condition, cause traced to intentional off-label, unapproved, or contraindicated use and supporting evidence that came to this conclusion.The farawave catheter was used to perform ablation outside the indicated lesion set, including ablation of the left carina, cardiac floor/roof, and ra septal.Additionally, the subsequent re-ablation included pfa of the superior vena cava, which is outside the approved indication.There is no evidence of device malfunction or unintended device performance, and based on the available information, a definitive cause for the event could not be established.
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.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.

• Brand Name: FARAWAVE
• Common Device Name: See H11
• 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: 50173961
• Report Number: 2124215-2026-42379
• Device Sequence Number: 18613508
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)270323(10)36130399
• 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,Followup
• Report Date (Section B): 09/09/2026

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: 0036130399
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 07/28/2026; 08/18/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 08/18/2026; 09/09/2026
• Date Device Manufactured: 03/23/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 180 LB