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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 Defective Device (2588)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/10/2019
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 foot pedal was acting "squirrely." during an ablation procedure, the foot pedal was acting "squirrely." no patient complications were reported.No further or specific information was available.
 
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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 Key8889885
Report Number2134265-2019-09664
Device Sequence Number19554057
Product Code OAD
UDI-Device Identifier08714729861942
UDI-Public08714729861942
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P020025
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/13/2019
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 Number0206170404
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2019
Initial Report FDA Received Date08/13/2019
Patient Sequence Number1
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