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	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2021
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 a intellanav mifi open-irrigated ablation catheters and a maestro connection box were used in a atrial fibrillation ablation procedure.Intellanav mifi oi was connected recognized by maestro generator, normal impedance was listed (123 ohms) temperature of catheter was low around 25 degrees celsius.When starting the first ablation with a power of 30 watts and flow of 30ml the temperature dropped below 15 degrees celsius, and a d06 temp out of range error was displayed.This error stopped the ablation.All connections were checked and no issues were identified.A second ablation was attempted and the same d06 error occurred.The output was lowered to 25 watts with irrigation of 17ml, temperature stayed above 15 degrees.The ablation catheter, connection cables, and maestro pod were swapped without solving the problem.With a flow of 10ml and power of 30 watts more ablations were attempted but it is not sure if these were effective.Temperature with these settings was around 18 degrees celsius.Isolation of inferior part of left pulmonary valves were attempted and an anterior and posterior line was done.The procedure was canceled due to this issue.

• Brand Name: MAESTRO 4000 CONTROLLER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11229676
• Report Number: 2134265-2021-00771
• Device Sequence Number: 3717692
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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: 0919180968
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1