MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE NAV; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number	0036080089
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pericardial effusion.During a pulsed field ablation (pfa) procedure to treat atrial fibrillation (af) a farawave catheter was selected for use.The physician struggled to get into the right pulmonary veins.The physician withdrew the sheath and tried to do another transeptal but was having complications.In the end, the physician tried again with the faradrive sheath and managed to ablate with the catheter on the right side.After withdrawing the sheath out of left atrium, a small pericardial effusion was seen.The ablation had been taking place for four hours when the complication was observed and occurred after the farawave catheter was pulled out of the left atrium.After 20 minutes, the patient blood pressure dropped to 70mmhg and the physician decided to drain the blood.A drainage was left in the patient.The patient is expected to fully recover from the event.The patient hospital stay was extended in response to the complication.The device is not expected to return as it was disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
B5: describe event or problem - updated.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient experienced pericardial effusion.During a pulsed field ablation (pfa) procedure to treat atrial fibrillation (af) a farawave catheter was selected for use.The physician struggled to get into the right pulmonary veins.The physician withdrew the sheath and tried to do another transeptal but was having complications.In the end, the physician tried again with the faradrive sheath and managed to ablate with the catheter on the right side.After withdrawing the sheath out of left atrium, a small pericardial effusion was seen.The ablation had been taking place for four hours when the complication was observed and occurred after the farawave catheter was pulled out of the left atrium.After 20 minutes, the patient blood pressure dropped to 70mmhg and the physician decided to drain the blood.A drainage was left in the patient.The patient is expected to fully recover from the event.The patient hospital stay was extended in response to the complication.The device is not expected to return as it was disposed.It was further reported that as of (b)(6) 2025, the patient was considered to be fine and stable.The procedure was completed before the complication occurred.

• Brand Name: FARAWAVE NAV
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• 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 ; 6514400979
• MDR Report Key: 23255565
• Report Number: 2124215-2025-71702
• Device Sequence Number: 18684031
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)260317(10)0036080089
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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 Expiration Date: 03/17/2026
• Device Lot Number: 0036080089
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/27/2025
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male