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 Codes	No Display/Image (1183); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
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 unit was not burning at the desired temperature.During a procedure the maestro 4000 controller temperature control light did not turn on when in temperature control mode.The user noted that the unit was not burning at the desired temperature.The procedure was completed with the unit and no patient complications occurred.
Additional Manufacturer Narrative
F10 device codes corrected.The device was returned for analysis at stellartech.There was no visual damage noted to the device during incoming service inspection at stellartech.The tamper proof seal was present but broken.The root cause of the unit temperature control light not turning on when in that mode was attributed to a defective led2 on the front panel board.Following replacement of this led, performed sub assembly bezel test with no other problem found.The device then passed all performance criteria of its final test prior to its shipment.Power output zsense test was performed as stress test.It passed the stress test.Temperature was set at 70 degrees c, then the temperature rise was confirmed on display screen while heating blazer ii electrode with a heat gun.Src investigation included post, power output and zsense test at ambient and environmental stress test, with no occurrence of the customer's reported complaint of "unit was not burning at desire temp." this possibly was related to externally connected equipment and/or test set up.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 unit was not burning at the desired temperature.During a procedure the maestro 4000 controller temperature control light did not turn on when in temperature control mode.The user noted that the unit was not burning at the desired temperature.The procedure was completed with the unit and no patient complications occurred.

• 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: 8843183
• Report Number: 2134265-2019-08988
• Device Sequence Number: 289880
• Product Code: OAD
• UDI-Device Identifier: 08714729861942
• UDI-Public: 08714729861942
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/08/2019

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: 0051115014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1