MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARMAP; CATHETER, ELECTRODE RECORDING

Model Number	M004CRBS7210
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter shaft was damaged or defective.During preparation prior to a procedure for treating atrial fibrillation (afib), a polarmap catheter was selected for use.It was observed that the catheter became stuck in the tuohy valve and could not be retracted.Upon release, slight damage or shearing of the catheter shaft near the electrodes was noted.An attempt was made to loosen the tuohy valve to free the catheter without causing further damage, but it was unsuccessful.The procedure was completed using a different device of the same model.No patient complications occurred.The device was disposed of by the facility and will not be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: POLARMAP
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 22645789
• Report Number: 2124215-2025-50022
• Device Sequence Number: 21023514
• Product Code: DRF
• UDI-Device Identifier: 00191506039769
• UDI-Public: (01)00191506039769(17)251105(10)32797513
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K223824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2025
• Device Model Number: M004CRBS7210
• Device Catalogue Number: M004CRBS7210
• Device Lot Number: 0032797513
• 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: 07/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Date Device Manufactured: 11/06/2023
• 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
• Patient Sex: Unknown