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 4000 POD, 150W; 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 4000 POD, 150W; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 86258
Device Problems Output below Specifications (3004); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2022
Event Type  malfunction  
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 Description
During an atrioventricular node (av) ablation procedure, a maestro 4000 was selected for use.It was reported that no av block was achieved during the procedure.The clinician was getting low power repeatedly due temperature spikes/wrong readings.As a result, the procedure was canceled.No patient complications were reported.
 
Manufacturer Narrative
The complaint device was returned and analyzed by the sfmd.The returned device analysis showed that the rf pod cable had a failure, the issue was resolved after replacement of this part.The reported event was confirmed to be caused by a component failure.
 
Event Description
During an atrioventricular node (av) ablation procedure, a maestro 4000 was selected for use.It was reported that no av block was achieved during the procedure.The clinician was getting low power repeatedly due temperature spikes/wrong readings.As a result, the procedure was canceled.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAESTRO 4000 POD, 150W
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
560 cottonwood dr.
milpita CA 95035
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key14322532
MDR Text Key291201241
Report Number2134265-2022-05294
Device Sequence Number1
Product Code OAD
Combination Product (y/n)N
Reporter Country CodeNZ
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,Followup
Report Date 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number86258
Device Catalogue Number86258
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/18/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-