MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 POD, 100W; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86258
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	12/11/2020
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 maestro 4000 controller was used in a ablation procedure.It was noted that the unit is not ablating when the foot pedal is engaged.It was reported that the procedure was canceled due to this event.
Event or Problem Description
It was reported that a maestro 4000 controller was used in a ablation procedure.However it was noted that the unit is not ablating when the foot pedal is engaged.It was reported that the procedure was canceled due to this event.It was further reported that the culprit device was a maestro 4000 pod not the controller.
Additional Manufacturer Narrative
Based on additional information suspect medical device was corrected from maestro 4000 controller to maestro 4000 pod, 100w.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 maestro 4000 controller was used in a ablation procedure.However it was noted that the unit is not ablating when the foot pedal is engaged.It was reported that the procedure was canceled due to this event.It was further reported that the culprit device was a maestro 4000 pod not the controller.
Additional Manufacturer Narrative
Based on additional information suspect medical device was corrected from maestro 4000 controller to maestro 4000 pod, 100w.Device technical analysis: visual inspection of the device showed no malfunction or damage outside the bounds of normal medical use.During functional testing the device passed functional testing.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: MAESTRO 4000 POD, 100W
• 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: 11156314
• Report Number: 2134265-2021-00211
• Device Sequence Number: 14100805
• Product Code: LPB
• UDI-Device Identifier: 08714729861911
• UDI-Public: 08714729861911
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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: 86258
• Device Catalogue Number: 86258
• Device Lot Number: 0613170437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 03/05/2021; 04/05/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/22/2021; 05/04/2021
• Patient Sequence Number: 1