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	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure, a maestro 4000 controller was selected for use.Following the radiofrequency delivery of some points, the maestro 4000 rf generator suddenly stopped working, no longer recognizing the ablator catheter despite the fact that on the rhythmia system the catheter was showing.The error shown on the maestro is "finding catheter.".The catheter connection cables and the ablation catheter were replaced, however the issue persisted.The systems were restarted but the problem could not be resolved.The procedure could not be completed due to this event.No patient complications were reported.It was also noted that the recognition issue occurred at initial connection.As the issue occurred during use, it was able to track the location of the catheter on opal mapping system and see cardiac data on screen.The catheter was able to be physically connected successfully.There were no noisy electrodes.There were no recent changes in lab setup.The patient was sedated with general anesthesia at the time of the procedure cancellation.Equipment replacement was requested.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 21766745
• Report Number: 2124215-2025-20522
• Device Sequence Number: 20948246
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: (01)08714729861911(11)210304
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 0304211851
• 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: 03/07/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown