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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the footswitch could not halt ablation.During a myocardial ablation procedure, the maestro 4000 footswitch stopped working after several ablations, and energization could not be turned off.The physician needed to step on the footswitch again to turn off ablation.The footswitch continued to be used, but the issue did not reoccur.The procedure was completed successfully, and there were no serious injuries or adverse patient effects.

• 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: 9309655
• Report Number: 2134265-2019-13710
• Device Sequence Number: 16677268
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• 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): 11/12/2019

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: 0338125012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1