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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pericardial effusion, perforation of the left atrial appendage (laa), and a drop in blood pressure.During a pulse field ablation (pfa) procedure to treat atrial fibrillation a farawave catheter was used.The transseptal puncture was performed, then a non-boston scientific catheter and sheath were inserted to perform pre-mapping.Resistance was felt when manipulating these devices anteriorly.Once the pre-map was complete the farawave catheter was introduced via the non-boston scientific sheath.After four ablation deliveries to the left superior pulmonary vein (lspv) with the catheter a significant drop in blood pressure occurred with systolic pressure in the mid-60s.Intracardiac echocardiography (ice) was used to check for pericardial effusion, and a significant pericardial effusion was observed.The catheter and sheath were then removed from the left atrium (la), and protamine was given because it was decided to cancel the procedure.Pericardiocentesis was performed and 2l of blood was removed.The patient was sent afterwards to the operating room (op) for a sternotomy.The cardiothoracic surgeon noted there was significant bleeding coming from the laa, which was identified as the perforation location.The laa was clipped and blood pressure returned to normal metrics.The patient was discharged from the hospital.
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.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.

• Brand Name: FARAWAVE?
• 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: 50613360
• Report Number: 2124215-2026-47321
• Device Sequence Number: 18800042
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/23/2026

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: 09/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 180 LB