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	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation to treat supraventricular tachycardia (svt), there was noise on the radiofrequency channels from the maestro 4000.The noise was consistent, high frequency, observed from the start of the case on the recording system.The catheter was replaced to resolve the issue, but the procedure was cancelled.The patient was under local anesthesia.There were no patient complications.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

• 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: 16096512
• Report Number: 2124215-2022-55750
• Device Sequence Number: 6669198
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2023

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: 0831201598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown