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); Nausea (1970); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	01/06/2025
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
Clinical study (b)(6) for polarx pas; subject id # (b)(6).It was reported that post procedure, the patient experienced nausea, hypotension and was subsequently diagnosed with cardiac tamponade and pericardial effusion, which required surgical intervention.During a pulmonary vein isolation cryoablation procedure, a polarx fit catheter was selected for use.Post treatment, the patient experienced episodes of nausea and hypotension.An urgent echocardiogram and ultrasound were performed and showed a moderate-sized pericardial effusion, 1.8cm at max.This effusion caused cardiac tamponade.The patient was taken to the cath lab where a pericardiocentesis was performed and 275cc of sanguinous drainage was removed.This event resulted in in-patient hospitalization or prolongation of existing hospitalization.The patient was discharged on (b)(6) 2025, imaging performed (ultrasound) showed that the issue had resolved.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
B5: describe event or problem - updated to provide additional details regarding the patient condition and intervention provided via ai record.H6: patient coding - correction to exclude pericardial effusion, cardiac tamponade captures this.H6: impact coding - addition of medication required to capture iv meds given as further reported via ai.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 nausea, hypotension and was subsequently diagnosed with cardiac tamponade and pericardial effusion, requiring surgical intervention.During a pulmonary vein isolation cryoablation procedure, a polarx fit catheter was selected for use.Post treatment, the patient experienced episodes of nausea and hypotension.An urgent echocardiogram and ultrasound was performed and showed a moderate-sized pericardial effusion, 1.8cm at max.This effusion caused cardiac tamponade.The patient was taken to the cath lab where a pericardiocentesis was performed and 275cc of sanguineous drainage was removed.This event resulted in in-patient hospitalization or prolongation of existing hospitalization.The patient was discharged on (b)(6)2025, imaging performed (ultrasound) showed that the issue had resolved.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 clarified that on (b)(6)2024, post drainage of the effusion, the patient continued to experience hypotension (blood pressure fell into the 80's).The patient was started on a norepinephrine iv drip for approximately 6 hours.The norepinephrine drip was stopped, and a dopamine drip was started.Again, they confirmed that ultrasound showed that the issue had resolved on (b)(6)2025 and the patient was discharged on (b)(6)2025.

• 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: 21267199
• Report Number: 2124215-2025-04481
• Device Sequence Number: 3664758
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 11/02/2025
• Device Model Number: M004CRBS2060
• Device Catalogue Number: M004CRBS2060
• Device Lot Number: 0032785070
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 11/03/2023
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown