MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARX? FIT; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	M004CRBS2060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a pericardial effusion.During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, a polarx catheter was selected for use.Following treatment of all four pulmonary veins and removal of the polarx catheter, intracardiac echocardiography (ice) was used to visualize the pericardium.An effusion was noted.This effusion was not apparent at baseline.Protamine was administered.There were no changes in hemodynamics during the case that would indicate the presence of an effusion.The effusion was monitored for the next 30 min with ice and a transthoracic echocardiogram (tte) was performed.The effusion was most notable at the basal aspect of the right ventricle and measured approximately 2.1 cm at its largest point.During monitoring, ultrasound contrast was administered intravenously and was assessed to see if it entered the pericardial space.No contrast entered the pericardial space.The patient's hemodynamics were not altered at all during this period.There was limited space to perform a pericardiocentesis as the effusion size was fairly small during diastole.It was decided that a pericardiocentesis would not be performed.The physician noted that the product was in working order and did not think it was the cause of the effusion.The transeptal was also uneventful and was fully visualized under ice.The patient was admitted for monitoring and has since been discharged with no further intervention needed.The effusion resolved on its own.The device was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.
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.

• Brand Name: POLARX? FIT
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 22886494
• Report Number: 2124215-2025-59312
• Device Sequence Number: 9057633
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622(17)270113(10)35615695
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P220032
• 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
• Report Date (Section B): 08/25/2025

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 Model Number: M004CRBS2060
• Device Catalogue Number: M004CRBS2060
• Device Lot Number: 0035615695
• 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: 08/05/2025
• Initial Report FDA Received Date: 08/25/2025
• Date Device Manufactured: 01/13/2025
• 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; Other
• Patient Sex: Unknown