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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 86250
Medical Device Problem Codes Device Remains Activated (1525); Defective Device (2588)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event or Problem Description
It was reported that ablation could not be halted.During an ablation procedure, the generator was energized with the maestro foot switch, but ablation was unable to be turned off.No serious injuries or adverse patient effects occurred.
 
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Brand Name
MAESTRO FOOT SWITCH
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 Key9495178
Report Number2134265-2019-15985
Device Sequence Number1202961
Product Code OAD
UDI-Device Identifier08714729862437
UDI-Public08714729862437
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
P020025
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/19/2019
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 Number86250
Device Catalogue Number86250
Device Lot Number0323192003
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/25/2019
Initial Report FDA Received Date12/19/2019
Patient Sequence Number1
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