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	08/30/2019
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 radio frequency (rf) ablation.During an ablation procedure, when the physician came off ablation with the maestro foot switch, the generator continued to deliver rf and continued making the sound of rf.The physician double tapped the foot pedal to come off ablation.No patient injury occurred and the case was completed successfully with no other issues.
Event or Problem Description
It was reported that there was a failure to halt radio frequency (rf) ablation.During an ablation procedure, when the physician came off ablation with the maestro foot switch, the generator continued to deliver rf and continued making the sound of rf.The physician double tapped the foot pedal to come off ablation.No patient injury occurred and the case was completed successfully with no other issues.It was further reported that the procedure was to treat atrial fibrillation.
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.

• 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: 8982654
• Report Number: 2134265-2019-10948
• Device Sequence Number: 3380358
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 0355293002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1