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	01/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that footswitch failed to halt ablation.It was reported that during ablation the maestro 4000 footswitch stuck and the ablation had to be manually turned off.There were no patient complications reported.The procedure was completed with the same maestro and foot pedal.
Event or Problem Description
It was reported that footswitch failed to halt ablation.It was reported that during ablation the maestro 4000 footswitch stuck and the ablation had to be manually turned off.There were no patient complications reported.The procedure was completed with the same maestro and foot pedal.
Additional Manufacturer Narrative
The foot switch was returned for evaluation.The foot guard was in overall good physical condition.Strain relief guard over cord was in good physical shape.No damage to cord's insulation jacket.Pedal presses down evenly with normal clicking sound.Connector to maestro is in good physical shape.Pins straight and grounding shield intact.Using an ohm meter, the foot switch was placed on the floor and activated.The switch turned on off with no issues.The cord was pulled and flexed along the length and near the connector and pedal's strain reliefs.No issues observed.There were no electrical or mechanical failures were found with this foot switch.It passed all testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Additional Manufacturer Narrative
The foot switch was returned for evaluation.The foot guard was in overall good physical condition.Strain relief guard over cord was in good physical shape.No damage to cord's insulation jacket.Pedal presses down evenly with normal clicking sound.Connector to maestro is in good physical shape.Pins straight and grounding shield intact.Using an ohm meter, the foot switch was placed on the floor and activated.The switch turned on off with no issues.The cord was pulled and flexed along the length and near the connector and pedal's strain reliefs.No issues observed.There were no electrical or mechanical failures were found with this foot switch.It passed all testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that footswitch failed to halt ablation.It was reported that during ablation the maestro 4000 footswitch stuck and the ablation had to be manually turned off.There were no patient complications reported.The procedure was completed with the same maestro and foot pedal.

• 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: 8289533
• Report Number: 2134265-2019-00583
• Device Sequence Number: 19508549
• Product Code: OAD
• UDI-Device Identifier: 08714729862437
• UDI-Public: 08714729862437
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2019

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: 0339774024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 04/25/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 04/10/2019; 05/21/2019
• Patient Sequence Number: 1