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 Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foot switch failed to halt ablation.It was reported that during ablation with an maestro 4000 system the footswitch "blocks" and failed to halt ablation.No patient complications were reported.
Additional Manufacturer Narrative
The rf 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 and pins straight and grounding shield intact.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.There were no electrical or mechanical failures were found with this foot switch.The maestro controller's firmware code was examined.It was discovered that there is a brief window in which the ablation termination command from the foot switch can go undetected.Resulting in the maestro 4000 staying on and continue to ablate.This does not exist in the maestro 3000 firmware codebase.The exact conditions when the termination command goes undetected in the field cannot be determined.It appears the fault condition could be caused by a design in the firmware coding.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that foot switch failed to halt ablation.It was reported that during ablation with an maestro 4000 system the footswitch "blocks" and failed to halt ablation.No patient complications were reported.

• 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: 8257996
• Report Number: 2134265-2018-65208
• Device Sequence Number: 19313483
• Product Code: OAD
• UDI-Device Identifier: 08714729861942
• UDI-Public: 08714729861942
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 050514005M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/10/2019
• Patient Sequence Number: 1