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	Chest Pain (1776); Fatigue (1849)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced severe chest discomfort following a cryoablation procedure.On (b)(6) 2026, the patient underwent a cryoablation procedure using a polarx fit balloon catheter.The procedure was completed successfully.Subsequently, the patient began expressing severe chest discomfort and inability to exercise due to fatigue on (b)(6) 2026.An adjustment in oral medication was prescribed, and ecg diagnostic tests were performed.The patient was reported to be in stable condition with a resolution date of (b)(6) 2026.
Additional Manufacturer Narrative
Investigation summary: the device was discarded; therefore, a technical analysis could not be performed.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was completed and confirmed that the events of chest pain and fatigue were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; +1(651)440-0979
• MDR Report Key: 50062988
• Report Number: 2124215-2026-40492
• Device Sequence Number: 15790062
• Product Code: OAE
• UDI-Device Identifier: 08714729992622
• UDI-Public: (01)08714729992622(17)271002(10)37607695
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P220032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 0037607695
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 10/02/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 97251520-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 175 LB