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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 86248
Device Problem Device Remains Activated (1525)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2019
Event Type  malfunction  
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 Description
It was reported that the device failed to halt (radiofrequency) rf delivery.During an ablation procedure with a maestro 4000 controller, the maestro foot switch foot pedal got stuck when ablating and would not turn ablation off.Patient complications were not reported.No further information was provided.
 
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 Description
It was reported that the device failed to halt (radiofrequency) rf delivery.During an ablation procedure with a maestro 4000 controller, the maestro foot switch foot pedal got stuck when ablating and would not turn ablation off.Patient complications were not reported.No further information was provided.It was further reported that the procedure was performed for atrioventricular reentrant tachycardia (avnrt).The malfunction occurred during the last energy application, so the procedure was completed.No patient complications occurred.
 
Manufacturer Narrative
The device was returned for analysis.The foot guard was missing two feet.The rest was in over all good physical condition.Strain relief guard over cord was in good physical shape.No damage to cord's insulation jacket.Pedal presses down evenly with normal clicking sound.Connector to maestro was in good physical shape.Pins straight and grounding shield intact.Using an ohm meter, the foot switch was placed on the floor and activated.The switch turned on off with no issues.The cord was pulled and flexed along the length and near the connector and pedal's strain reliefs.No issues observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that the device failed to halt (radiofrequency) rf delivery.During an ablation procedure with a maestro 4000 controller, the maestro foot switch foot pedal got stuck when ablating and would not turn ablation off.Patient complications were not reported.No further information was provided.It was further reported that the procedure was performed for atrioventricular reentrant tachycardia (avnrt).The malfunction occurred during the last energy application, so the procedure was completed.No patient complications occurred.
 
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Brand Name
MAESTRO 4000 CONTROLLER
Type of Device
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 Key8522461
MDR Text Key142200127
Report Number2134265-2019-03989
Device Sequence Number1
Product Code LPB
UDI-Device Identifier08714729861911
UDI-Public08714729861911
Combination Product (y/n)N
PMA/PMN Number
P020025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/27/2019
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
Device Operator Health Professional
Device Model Number86248
Device Catalogue Number86248
Device Lot Number1110150173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Initial Date Manufacturer Received 03/21/2019
Initial Date FDA Received04/17/2019
Supplement Dates Manufacturer Received04/23/2019
11/14/2019
Supplement Dates FDA Received04/26/2019
11/27/2019
Patient Sequence Number1
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