MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86248
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
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
It was reported that the pod could not recognize the catheter and displayed an error.Subsequently the procedure was cancelled post sedation.This is being reported for cancellation of the procedure post sedation.During an electrophysiology procedure, a maestro 4000 controller was selected for use.The unit suddenly stopped functioning and was unable to recognize the ablation catheter, despite the catheter being visible on the rhythmia system.The system displayed a finding catheter message.The issue was unable to be resolved, and the procedure was canceled.The patient was under conscious sedation during the time of cancellation.No patient complications were reported.
Additional Manufacturer Narrative
Correction to the initial mdr in block e3.Upon receipt at our post market quality assurance laboratory, the returned maestro controller and pod were visually inspected, and no problems were found.During functional testing, the controller and pod were connected with a known-good maestro and rhythmia system.Ten ablations were performed successfully at 50w with no errors presented.With all available information, the reported event of "message- d10 invalid catheter id" could not be confirmed as the device passed all testing, and no evidence or problems were observed during the analysis.
Event or Problem Description
It was reported that the pod could not recognize the catheter and displayed an error.Subsequently the procedure was cancelled post sedation.This is being reported for cancellation of the procedure post sedation.During an electrophysiology procedure, a maestro 4000 controller was selected for use.The unit suddenly stopped functioning and was unable to recognize the ablation catheter, despite the catheter being visible on the rhythmia system.The system displayed a finding catheter message.The issue was unable to be resolved, and the procedure was canceled.The patient was under conscious sedation during the time of cancellation.No patient complications were reported.

• Brand Name: MAESTRO 4000 CONTROLLER
• 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): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23476650
• Report Number: 2124215-2025-79753
• Device Sequence Number: 10494350
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: (01)08714729861911(11)141125
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: IT
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 0112514004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown