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	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2019
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 there was a failure to halt radiofrequency (rf) ablation delivery.During an ablation procedure, while ablating with the foot pedal, energization continued even when the foot pedal was removed.Energization was stopped via an off switch on the main unit.There were no reported patient issues and the patient outcome was "good.".

• Brand Name: MAESTRO 4000 CONTROLLER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9203586
• Report Number: 2134265-2019-12636
• Device Sequence Number: 2950443
• Product Code: LPB
• UDI-Device Identifier: 08714729861935
• UDI-Public: 08714729861935
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 0404170425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1