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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 Code Device Remains Activated (1525)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported that a maestro foot switch was used in a ablation procedure.When the foot pedal was used no response occurred.The procedure was completed using another foot pedal was used with no patient complications being reported.
 
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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
300 boston scientific way
marlborough MA 01752
MDR Report Key10459511
Report Number2134265-2020-11840
Device Sequence Number16878664
Product Code OAD
UDI-Device Identifier08714729862437
UDI-Public08714729862437
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P920047
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) 08/27/2020
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 Number0339857024
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/11/2020
Initial Report FDA Received Date08/27/2020
Patient Sequence Number1
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