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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
Device Problem Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2023
Event Type  malfunction  
Event Description
It was reported that the maestro 4000 system had a recurring temperature issue.When using an unspecified non-irrigated catheter the temperature was lower than normal at around 17-18 vs 30 degrees.Sometimes the physician would have to stop ablating because the error code of d06 temp out of range would occur.No patient complications were reported.No further information was provided.It is unknown if the device will be returned.
 
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.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
STELLARTECH RESEARCH CORPORATION
CA
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key17291863
MDR Text Key319034681
Report Number2124215-2023-34203
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodeVM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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