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	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/10/2024
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
Polarx pas clinical study.It was reported that a perforation, pericardial effusion and cardiac tamponade occurred.A polarx fit ablation catheter and intellamap orion diagnostic catheter was selected for ablation treatment to the left inferior pulmonary vein.It was noted that the systolic blood pressure was 70s.It was suspected that the intellamap orion perforated the left artria during initial mapping.Therefore, examination of intracardiac ultrasound was performed which then revealed a 1cm effusion.Given the new effusion, procedure was terminated and left femoral arterial line was obtained as pericardiocentesis was performed.Chest was prepped and draped in usual sterile fashion and ultrasound guidance was used which noted subxiphoid distance to the pericardium was closer to 8 to 0cm.Left parasternal ultrasound view was much better and only 4cm away and therefore was used for access without difficulties.Wire in the pericardium circumscribing the cardiac shadow was confirmed on fluoroscopy.A total of 450cc of bright blood was removed from the pericardium without difficulty and blood pressure resumed and ultrasound confirmed complete resolution of the pericardial effusion.Drain connected to the pericardial drain.Ongoing monitoring of the effusion was performed with minimal ongoing bleed.Comprehensive intracardiac echo evaluation with arrhythmia induction was repeated post ablation, and post-ablation intracardiac echo evaluation was consistent with pre ablation with no changes and no pericardial effusion and there is no left atrial thrombus or left ventricle thrombus seen.Protamine iv was given at end of procedure, and catheters and sheaths were removed at the end of the procedure.There were no apparent complications.The patient was arousable and moving all limbs at end of procedures.No further patient complications were reported.
Event or Problem Description
Polarx pas clinical study.It was reported that a perforation, pericardial effusion and cardiac tamponade occurred.A polarx fit ablation catheter and intellamap orion diagnostic catheter was selected for ablation treatment to the left inferior pulmonary vein.It was noted that the systolic blood pressure was 70s.It was suspected that the intellamap orion perforated the left artria during initial mapping.Therefore, examination of intracardiac ultrasound was performed which then revealed a 1cm effusion.Given the new effusion, procedure was terminated and left femoral arterial line was obtained as pericardiocentesis was performed.Chest was prepped and draped in usual sterile fashion and ultrasound guidance was used which noted subxiphoid distance to the pericardium was closer to 8 to 0cm.Left parasternal ultrasound view was much better and only 4cm away and therefore was used for access without difficulties.Wire in the pericardium circumscribing the cardiac shadow was confirmed on fluoroscopy.A total of 450cc of bright blood was removed from the pericardium without difficulty and blood pressure resumed and ultrasound confirmed complete resolution of the pericardial effusion.Drain connected to the pericardial drain.Ongoing monitoring of the effusion was performed with minimal ongoing bleed.Comprehensive intracardiac echo evaluation with arrhythmia induction was repeated post ablation, and post-ablation intracardiac echo evaluation was consistent with pre ablation with no changes and no pericardial effusion and there is no left atrial thrombus or left ventricle thrombus seen.Protamine iv was given at end of procedure, and catheters and sheaths were removed at the end of the procedure.There were no apparent complications.The patient was arousable and moving all limbs at end of procedures.No further patient complications were reported.It was further reported that the outcome of event was resolved on 02jan2025.
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.Detailed product lot number information was not provided to bsc.Because the product is lot number is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• 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: 20957137
• Report Number: 2124215-2024-79853
• Device Sequence Number: 7674550
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622
• 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): 05/05/2025

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
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION DIAGNOSTIC CATHETER; INTELLAMAP ORION DIAGNOSTIC CATHETER; POLARMAP DIAGNOSTIC CATHETER; POLARMAP DIAGNOSTIC CATHETER; POLARSHEATH STEERABLE SHEATH ACCESS SHEATH; POLARSHEATH STEERABLE SHEATH ACCESS SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 99 KG