MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 3000; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86320
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2019
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 foot pedal was unresponsive.During an ablation procedure, an issue occurred with the maestro console where the foot pedal became unresponsive and would not react anymore.No patient issues were reported.

• Brand Name: MAESTRO 3000
• 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: 9250072
• Report Number: 2134265-2019-13113
• Device Sequence Number: 19340621
• Product Code: OAD
• UDI-Device Identifier: 08714729811923
• UDI-Public: 08714729811923
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 10/29/2019

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: 86320
• Device Catalogue Number: 86320
• Device Lot Number: 011907006M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1