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

Model Number	86252
Medical Device Problem Codes	Device Remains Activated (1525); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
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 stop button of the maestro 4000 remote control is not working the controller did not halt ablation, and the staff had to switch it off for stop.No further information was provided.
Additional Manufacturer Narrative
Device technical analysis: upon receipt at boston scientific's post market laboratory the allegation in this complaint has not been confirmed.The returned maestro remote control was able to start and stop 10 ablations at random intervals.
Event or Problem Description
It was reported that the stop button of the maestro 4000 remote control is not working, and the staff had to switch it off for stop.No further information was provided.Additional information was received that clarified the button on/off not working.The procedure was completed without patient complications.Issue was identified during ablation procedure, and the device was replaced.

• Brand Name: MAESTRO 4000 REMOTE CONTROL
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19556885
• Report Number: 2124215-2024-36898
• Device Sequence Number: 6730657
• Product Code: OAD
• UDI-Device Identifier: 08714729862062
• UDI-Public: 08714729862062
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 86252
• Device Catalogue Number: 86252
• Device Lot Number: 0325200761
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown