MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86248
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that the foot pedal of the maestro 4000 controller failed to halt radiofrequency (rf) delivery.During an ablation procedure, the maestro foot pedal would get "stuck" at random times throughout the case.Patient adverse events were not 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: 9220055
• Report Number: 2134265-2019-12815
• Device Sequence Number: 19516522
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• 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
• Report Date (Section B): 10/22/2019

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: 86248
• Device Catalogue Number: 86248
• Device Lot Number: 1117170660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1