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

Model Number	86320
Medical Device Problem Codes	Mechanical Problem (1384); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
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.
Event or Problem Description
It was reported that he maestro 3000 generator inadvertently delivered radiofrequency (rf) energy.During an ablation procedure for right atrial flutter, using a "non-nav xp catheter", the generator delivered 40 seconds of rf energy without a command to do so.The foot pedal, generator and remote were untouched; "the rf energy came on all by itself".It was not possible to reproduce the incident; however, it was observed that the foot pedal connection was loose in the back of the generator.The generator was at end-of-life.There were no patient complications and the procedure was completed with a maestro 4000 generator.

• 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: 9199158
• Report Number: 2134265-2019-12591
• Device Sequence Number: 3107472
• Product Code: OAD
• UDI-Device Identifier: 08714729811923
• UDI-Public: 08714729811923
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/16/2019

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: 030807005M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1