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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Lot Number 0032527370
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
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
The intellanav stablepoint open-irrigated was selected for use during the procedure to treat atrial fibrillation (a fib).It was reported that cracks were visible in the three-way stopcock when catheter was opened, so device was replaced with another lot.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
 
Event Description
The intellanav stablepoint open-irrigated was selected for use during the procedure to treat atrial fibrillation (a fib).It was reported that cracks were visible in the three-way stopcock when catheter was opened, so device was replaced with another lot.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.
 
Manufacturer Narrative
Device evaluated by manufacturer: the intellanav stablepoint open-irrigated was returned for analysis.Visual inspection was performed, and the device passed visual inspection with no defects noted.Functional testing was performed, and the device passed functional testing.Analysis of returned product revealed that the device showed no evidence or defects that could have contributed to the reported event.With all the available information, boston scientific concludes no problem detected.
 
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Brand Name
INTELLANAV STABLEPOINT OPEN-IRRIGATED
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18895448
MDR Text Key337563537
Report Number2124215-2024-12482
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0032527370
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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