Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION MAESTRO FOOT SWITCH; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Device Problems Device Remains Activated (1525); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2019
Event Type  malfunction  
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 Description
It was reported that ablation could not be halted.During an ablation procedure, after several energizations, the maestro foot switch would no longer function, and energization could not be turned off.The ablation was turned off remotely on the generator.The case proceeded with the foot switch.No patient complications were reported.
 
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 Description
It was reported that ablation could not be halted.During an ablation procedure, after several energizations, the maestro foot switch would no longer function, and energization could not be turned off.The ablation was turned off remotely on the generator.The case proceeded with the foot switch.No patient complications were reported.It was further reported that the procedure was successfully completed without any serious injuries or adverse patient effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAESTRO FOOT SWITCH
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9495157
MDR Text Key176767443
Report Number2134265-2019-15984
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2019
Patient Sequence Number1
-
-