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

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hemolysis (1886); Hematuria (2558)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure, a farawave and versacross connect transseptal access product were selected for use.During the procedure, a total of 97 ablation applications were delivered, including 82 lesions to the pulmonary veins and posterior wall and 15 lesions to the cavotricuspid isthmus.Due to the high lesion count, the physician administered 1.5 l of intravenous fluids intraoperatively.No malfunctions were reported at this time.Following the procedure, the patient developed hematuria, and the physician indicated that the high number of ablation applications may have contributed to hemolysis and the subsequent hematuria.As a result, the patient was admitted to the hospital for overnight observation and received additional intravenous fluids.No diagnostic test results related to hemolysis were available.The hematuria resolved after treatment, and the patient was discharged the following day with no additional complications reported.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.It was confirmed that lot number is unknown.Therefore, bsc is unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• Brand Name: FARAWAVE
• Common Device Name: see H11
• 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: 50869894
• Report Number: 2124215-2026-50672
• Device Sequence Number: 9314607
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• 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: 08/31/2026
• Initial 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: Other; Hospitalization
• Patient Sex: Unknown