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	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional premarket / 510(k) #'s: p980003, p020025.
Event or Problem Description
It was reported that the generator controller exhibited low power.During a procedure a maestro 4000 controller was selected for use.The generator unit was not getting to max temperature and was staying at low power.Multiple catheters were attempted to be used with the equipment, but the issue remained.The controller was replaced with a different model device.The procedure was completed with no patient complications.The controller has been received at boston scientific's post market laboratory where it is awaiting analysis.
Event or Problem Description
It was reported that the generator controller exhibited low power.During a procedure a maestro 4000 controller was selected for use.The generator unit was not getting to max temperature and was staying at low power.Multiple catheters were attempted to be used with the equipment, but the issue remained.The controller was replaced with a different model device.The procedure was completed with no patient complications.The controller has been received at boston scientific's post market laboratory where it is awaiting analysis.
Additional Manufacturer Narrative
Additional premarket / 510(k) #'s: p980003, p020025.The maestro 4000 controller was returned and analyzed by the sfmd.The returned device analysis showed no evidence of defect, malfunction or damage upon visual inspection and functional testing.The reported error could not be reproduced, so the reported event was not confirmed.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16808518
• Report Number: 2124215-2023-15835
• Device Sequence Number: 19563315
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/20/2023

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: 0206170414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown