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 Codes	Atrial Fibrillation (1729); Pericarditis (4448)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Clinical study (b)(6) for polarx pas; subject id (b)(6).It was reported that post procedure, the patient experienced pericarditis requiring medical treatment.During a three (3) month follow-up post ablation procedure with a polarx catheter, the patient notified the physician that a few hours after discharge, they experienced pericarditis and recurrence of atrial fibrillation.The patient was treated at an outside facility where they underwent surgery and were prescribed oral medication; colchicine, flecainide and diltiazem.The patient condition has resolved.A request for the medical records was sent, updates pending once those records are received.No further information is available at this time.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.
Event or Problem Description
Clinical study (b)(6) for polarx pas; subject id (b)(6).It was reported that post procedure, the patient experienced pericarditis requiring medical treatment.During a three (3) month follow-up post ablation procedure with a polarx catheter, the patient notified the physician that a few hours after discharge, they experienced pericarditis and recurrence of atrial fibrillation.The patient was treated at an outside facility where they underwent surgery and were prescribed oral medication; colchicine, flecainide and diltiazem.The patient condition has resolved.A request for the medical records was sent, updates pending once those records are received.No further information is available at this time.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.It was further reported per additional information that the patient underwent an ablation procedure on (b)(6) 2024.On (b)(6) 2024, the patient presented to the emergency department at (b)(6) with chief complaints of chest pain and shortness of breath, just a few hours after being discharged from banner health care facility for pericarditis.Diagnostic tests, including labs and ekgs, were performed.Cardiology was consulted and noted that the patient chest pain and presentation seem very characteristic of post ablation pericarditis.Physician also noted this was a typical post ablation pericardial irritation and pain, expected.The patient was started on colchicine and high dose ibuprofen 600 mg three times a day for pain relief.An echocardiogram revealed 55-60 percent with no wall motion abnormalities or effusion, and an x-ray showed no acute disease in the chest.No invasive intervention took place.The patient was discharged on (b)(6) 2024.During the three month follow up, the patient confirmed to have completed the course of colchicine and that the pericarditis symptoms had resolved.Resolution date (b)(6) 2024.

• 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: 20902632
• Report Number: 2124215-2024-78095
• Device Sequence Number: 8906300
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622(17)250904(10)32355369
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: 09/04/2025
• Device Model Number: M004CRBS2060
• Device Catalogue Number: M004CRBS2060
• Device Lot Number: 0032355369
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 06/26/2025
• Date Device Manufactured: 09/05/2023
• 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: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 102 KG