MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT?; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004RFSDS9620K20
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the error message "the following electrodes have poor signal quality- electrode label" was displayed.This is being reported for cancellation of the procedure post sedation.During an ablation procedure to treat atrial fibrillation (afib), an intellanav stablepoint catheter was used.When connecting the device, significant signal was observed on bard on the distal electrode, and the opal system was confirmed to be working properly.However, the error message "the following electrodes have poor signal quality- electrode label" appeared.Troubleshooting steps included reconnecting the signal station and checking the reference patch and both ground pads.Despite troubleshooting, the procedure was cancelled due to technical problems and poor anatomical contact.There were no patient complications reported as a result of this event.The device has been received and is pending analysis.
Additional Manufacturer Narrative
The device has not yet been evaluated.Upon 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.
Event or Problem Description
It was reported that the error message "the following electrodes have poor signal quality- electrode label" was displayed.This is being reported for cancellation of the procedure post sedation.During an ablation procedure to treat atrial fibrillation (afib), an intellanav stablepoint catheter was used.When connecting the device, significant signal was observed on bard on the distal electrode, and the opal system was confirmed to be working properly.However, the error message "the following electrodes have poor signal quality- electrode label" appeared.Troubleshooting steps included reconnecting the signal station and checking the reference patch and both ground pads.Despite troubleshooting, the procedure was cancelled due to technical problems and poor anatomical contact.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the intellanav stablepoint was returned and did not display any visual defects.Functional, continuity, and electrical testing was performed and the intellanav stablepoint passed all tests.

• Brand Name: INTELLANAV STABLEPOINT?
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 23410395
• Report Number: 2124215-2025-77218
• Device Sequence Number: 10431638
• Product Code: OAD
• UDI-Device Identifier: 08714729992240
• UDI-Public: (01)08714729992240(17)270604(10)36682819
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• 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,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: M004RFSDS9620K20
• Device Catalogue Number: M004RFSDS9620K20
• Device Lot Number: 0036682819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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
• Patient Sex: Unknown