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 Codes	Use of Device Problem (1670); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that the error message d06 temp out of range occurred on the maestro 4000.When the issue occurred, a patient was on the table.They were unable to clear the error and the procedure was cancelled at that time.It is currently unknown if the device will be returned for analysis.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a radiofrequency (rf) cardiac ablation procedure, the maestro 4000 controller displayed a temperature out-of-range alertd06).Troubleshooting was performed by restarting the controller, checking all connections again, changing the connection cable of the catheter, and changing ablation catheter; however, the alert was unable to be cleared from the maestro 4000 controller.The procedure was cancelled.Additional information was received that the maestro 4000 controller remains at the hospital, and it will not be returned for laboratory analysis.It was determined that the cause of the event was not related to a product performance problem with the maestro 4000 controller but due to the user not following instructions provided in the maestro 4000 controller instructions for use (ifu).During the procedure, the customer was using an intellanav ablation catheter that was connected to the rhythmia hdx mapping system.Although the intellanav ablation catheter was connected to the rhythmia hdx mapping system, the rhythmia hdx mapping system was not switched to on.With the rhythmia hdx mapping system being off, no temperature data could be actively transmitted from the intellanav ablation catheter to the maestro 4000 controller, and as a result, the maestro 4000 controller displayed an out-of-range temperature alertd06), and the ablation could not be performed.A boston scientific field representative discussed this finding with the customer and no changes to the maestro 4000 controller or accessories were needed.The referenced maestro 4000 controller is operating as expected and remains in service at the hospital.
Additional Manufacturer Narrative
Device technical analysis the maestro 4000 controller remains at the hospital, and it will not be returned for laboratory analysis.Additional information determined that the cause of the temperature out-of-range alertd06) was due to the user not having the rhythmia hdx mapping system powered on while it was connected to the catheter and maestro 4000 controller as instructed in the maestro 4000 controller ifu.Report is being submitted to provide updates to the incident description including the status of the device, updates to the device analysis results, and imdrf inv.Conclusion codes.

• 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
• Manufacturer (Section G): STELLARTECH RESEARCH CORPORATION; 560 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20127312
• Report Number: 2124215-2024-54924
• Device Sequence Number: 7462796
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 0324201462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown