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

Model Number	M004CRBS2160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Atrial Fibrillation (1729); Chest Pain (1776); Fatigue (1849); Nausea (1970); Discomfort (2330)
Date of Event	10/08/2025
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
Per clinical study: polarx pas py003 it was reported that a polarx fit catheter was selected for use.Post procedure, on (b)(6) 2025, the patient presented to the emergency department with complaints of chest pain worsened by deep inhalation, along with nausea, fatigue, and malaise.Computed tomography imaging confirmed a left upper lobe pulmonary embolism.The patient was admitted to telemetry and started on heparin therapy.A venous duplex study was negative for deep vein thrombosis.Laboratory tests were also performed.During admission, the patient experienced an episode of atrial fibrillation.In the cardiologist's note dated (b)(6) 2025, it was stated: "continued paroxysms of atrial fibrillation can be seen in the immediate period following af ablation." the patient was started on multaq and subsequently discharged on the same day with this medication.Device is not expected to be returned as complications occurred post procedure, after the device was discarded.
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
Per clinical study: polarx pas py003 it was reported that a polarx fit catheter was selected for use.Post procedure, on october 8, 2025, the patient presented to the emergency department with complaints of chest pain worsened by deep inhalation, along with nausea, fatigue, and malaise.Computed tomography imaging confirmed a left upper lobe pulmonary embolism.The patient was admitted to telemetry and started on heparin therapy.A venous duplex study was negative for deep vein thrombosis.Laboratory tests were also performed.During admission, the patient experienced an episode of atrial fibrillation.In the cardiologist's note dated october 11, 2025, it was stated: "continued paroxysms of atrial fibrillation can be seen in the immediate period following af ablation." the patient was started on multaq and subsequently discharged on the same day with this medication.Device is not expected to be returned as complications occurred post procedure, after the device was discarded.It was further reported that on (b)(6) 2025, post procedure, the patient experienced hospitalization stasis after groin vein access, during which a small thrombus may have developed, potentially causing the pulmonary embolus.No residual deep vein thrombus was identified.Corrective actions were performed during hospitalization.On (b)(6) 2025, the patient received iv heparin, and additional iv heparin administrations occurred on (b)(6) 2025.On (b)(6) 2025, an oral medication adjustment was made with the initiation of multaq (dronedarone).

• 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: 23549907
• Report Number: 2124215-2025-82531
• Device Sequence Number: 18544036
• Product Code: OAE
• UDI-Device Identifier: 00191506016463
• UDI-Public: (01)00191506016463(17)270831(10)37339017
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: M004CRBS2160
• Device Catalogue Number: M004CRBS2160
• Device Lot Number: 0037339017
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/29/2025
• Date Device Manufactured: 08/31/2025
• 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; Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 67 KG