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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 0030410047
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2023
Event Type  malfunction  
Event Description
It was reported that during preparation for a catheter ablation procedure to treat atrial fibrillation an intellanav stablepoint open-irrigated was selected for use.During flushing, liquid leakage was observed from the luer.The flow rate was 60ml/min.Upon careful inspection it was found that part of the luer was torn.The catheter was replaced with another of the same model to complete the procedure.No patient complications.The device is expected to be returned for analysis.
 
Manufacturer Narrative
The intellanav stablepoint open-irrigated catheter was returned to boston scientific for laboratory analysis.A visual inspection found the irrigation extension tubing was partially detached/separated from the luer fitting at the adhesive joint.Laboratory analysis confirmed the reported clinical observation.
 
Event Description
It was reported that during preparation for a catheter ablation procedure to treat atrial fibrillation an intellanav stablepoint open-irrigated was selected for use.During flushing, liquid leakage was observed from the luer.The flow rate was 60ml/min.Upon careful inspection it was found that part of the luer was torn.The catheter was replaced with another of the same model to complete the procedure.No patient complications.The device has been returned for analysis.
 
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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 Key16847256
MDR Text Key314362715
Report Number2124215-2023-16258
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0030410047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2022
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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