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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 86338
Medical Device Problem Code Device Remains Activated (1525)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/14/2019
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 footswitch failed to halt ablation.During a right atrial flutter procedure involving a maestro 4000 cardiac ablation system, the maestro generator continued to deliver rf 5 to 10 seconds after have released the footswitch.No patient complications were reported.
 
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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 Key8780361
Report Number2134265-2019-08096
Device Sequence Number2665940
Product Code OAD
UDI-Device Identifier08714729861942
UDI-Public08714729861942
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P020025
Number of Events Summarized1
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) 07/11/2019
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 Number86338
Device Catalogue Number86338
Device Lot Number0020615004
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/14/2019
Initial Report FDA Received Date07/11/2019
Patient Sequence Number1
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