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

Lot Number	0038579856
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hemolysis (1886); Urinary Retention (2119)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an ablation procedure, a farawave was selected for use.Use of the catheter to treat cavo tricuspid isthmus and superior vena cava, constituted off-label use of the catheter.During procedure, a total of 87 ablations were performed at the pulmonary veins, posterior wall, cavo tricuspid isthmus and superior vena cava locations.The patient presented to the emergency room approximately 24 hours after the procedure due issues urinating- hemolysis.Diagnostic testing showed trace blood in the urine with 1 red blood cell/hpf, haptoglobin <10, bilirubin 4.1, ldh 4.69, and creatinine 0.8.The patient exhibited clinical signs consistent with hemolysis, including urinary retention.In response, the patient was admitted to the hospital and treated with intravenous (iv) fluids.The adverse event was considered possibly related to the catheter, although no device malfunction was noted.The patient condition improved, resulting in recovery and discharge from the hospital.
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.

• 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: 50584144
• Report Number: 2124215-2026-46861
• Device Sequence Number: 10351251
• Product Code: QZI
• UDI-Device Identifier: 00191506043148
• UDI-Public: (01)00191506043148(17)280211(10)38579856
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/18/2026

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: 0038579856
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 02/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 171 LB