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	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
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
The maestro 4000 generator was selected for use during the procedure of atrioventricular node ablation.It was reported that when temperature control setting was selected the generator failed to deliver enough ablation power.The temperature spiked.The operator replaced the generator with a non-boston scientific device to complete the procedure.No patient complications occurred.The generator is expected to return.
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
The maestro 4000 generator was selected for use during the procedure of atrioventricular node ablation.It was reported that when temperature control setting was selected the generator failed to deliver enough ablation power.The temperature spiked.The operator replaced the generator with a non-boston scientific device to complete the procedure.No patient complications occurred.The generator is expected to return.It was further reported that no error messages displayed.
Additional Manufacturer Narrative
Device technical analysis: the allegation in this complaint has not been confirmed due to returned generator passing all functional tests with no abnormalities seen.
Event or Problem Description
The maestro 4000 generator was selected for use during the procedure of atrioventricular node ablation.It was reported that when temperature control setting was selected the generator failed to deliver enough ablation power.The temperature spiked.The operator replaced the generator with a non-boston scientific device to complete the procedure.No patient complications occurred.The generator is expected to return.It was further reported that "no error messages were displayed and the device was replaced with a refurbished model.".

• 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: 19233258
• Report Number: 2124215-2024-26851
• Device Sequence Number: 6980894
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: 1114191365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 09/27/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/15/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown