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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 Known Impact Or Consequence To Patient (2692)
Date of Event 07/22/2019
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 the footswitch failed to halt radio frequency (rf) delivery.During an ablation procedure for atrial fibrillation, ablation continued after the foot pedal on the maestro 4000 controller was released.It was necessary for the physician to press the pedal and release it again to stop the ablation delivery.The procedure was successfully completed and there were no patient complications.
 
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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 Key8907917
Report Number2134265-2019-09942
Device Sequence Number19515570
Product Code OAD
UDI-Device Identifier08714729861942
UDI-Public08714729861942
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 08/19/2019
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
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2019
Initial Report FDA Received Date08/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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