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

Model Number	86338
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the maestro 4000 had temperature issue.When the radiofrequency is turned up on the console the temperature reading goes down.A device replacement was requested.No patient complication was reported.The event outcome is unknown.Device is expected to be returned for analysis.
Event or Problem Description
It was reported that the maestro 4000 had temperature issue.When the radiofrequency is turned up on the console the temperature reading goes down.A device replacement was requested.No patient complication was reported.The event outcome is unknown.Per additional information received, the maestro 4000 controller was repaired.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Correction to h8 usage of device.Initially reported as single use.Corrected to reuse.Device evaluated by manufacturer.The maestro 4000 controller was visually inspected, and no abnormalities were observed.The unit was tested for functionality and passed all testing and exhibited normal device characteristics.The reported failure could not be replicated as the device presented no issues during visual and functional testing.

• 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: 20446179
• Report Number: 2124215-2024-63089
• Device Sequence Number: 7995466
• Product Code: OAD
• UDI-Device Identifier: 08714729861942
• UDI-Public: (01)08714729861942(11)230124(21)124232026
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 86338
• Device Catalogue Number: 86338
• Device Lot Number: 0124232026
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown