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	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation as it was disposed of.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a patient experienced cardiac tamponade.Subsequently, the procedure was cancelled.During a cryoablation procedure to treat atrial fibrillation, a polarx fit catheter was selected for use.After performing a transseptal puncture using the versacross, the polarx fit catheter was inserted, and treatment of the left inferior pulmonary vein began.Approximately 100 seconds into the application, the patient's blood pressure dropped, and a double stop was initiated on the cryoablation system.It was noted that the patient had a small pericardial effusion/tamponade.Pericardial drainage was performed and completed at 8:52am.The patient was given 40 of protamine at 8:53am to reverse the heparin.A total of 100cc of blood was drawn out and at 9:48am, the drain still had no blood accumulation.Anesthesia was able to keep the patient stable throughout with little management and only 1 shot of epinephrin was given.The procedure was cancelled at this time.The patient left the room at 9:50am and was taken to the icu.The patient was alert and doing well post procedure.Patient was to remain in hospital for 2-3 days to be monitored but was expected to make a full recovery.It was later reported that the physician did not believe the products malfunctioned in any way and caused the event.Per the physician, the event was due to the normal risks associated with this type of procedure.The patient anatomy was a little difficult.No visualization difficulty was noted.No issues with tsp workflow.Heparin had been given prior to transseptal (ts) puncture, but the effusion was noted soon after ts and before the usual time an act is checked.In the physician opinion, the cardiac tamponade is believed to be the result of the transseptal puncture.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.

• 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: 21890282
• Report Number: 2124215-2025-25320
• Device Sequence Number: 17004745
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622(17)261216(10)35503053
• 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): 04/23/2025

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: 0035503053
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/23/2025
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Sex: Unknown