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

Model Number	86250
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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 the maestro 4000 foot switch failed to halt radiofrequency (rf) delivery.During an ablation procedure for typical atrial flutter, the maestro 4000 generator did not stop delivering power when foot pedal was released.The foot pedal was stepped on again, but didn't have an effect.It only stopped when the button was pushed on the generator itself.The procedure was completed successfully and no patient complications occurred.

• Brand Name: MAESTRO FOOT SWITCH
• 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: 9460204
• Report Number: 2134265-2019-15668
• Device Sequence Number: 2158968
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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: 86250
• Device Catalogue Number: 86250
• Device Lot Number: 0355292125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/12/2019
• Patient Sequence Number: 1
• Patient Age: 69 YR