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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 0028277637
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2022
Event Type  malfunction  
Event Description
It was reported that during a procedure with a intellanav stablepoint ablation catheter, it was difficult to advance the tip of the catheter to the target site since the curve would bent on the proximal side.The catheter could not be positioned properly and the ablation effect could not be observed; the electrogram amplitude could not be decreased properly.The potential was not depleted, there was an easy re-conduction of the block line, and a dormant conduction has also occurred several times.This catheter was not replaced and the procedure was completed with the ablation unfinished.There were no patient complications.The product has been returned to boston scientific and a laboratory analysis is expected to be completed.
 
Manufacturer Narrative
The intellanav stablepoint ablation catheter was returned to boston scientific for analysis.Visual inspection did not reveal any abnormalities.Functional testing noted no abnormal resistance while maneuvering the catheter.Dimensional tests were performed, the results showed that both curves reached the acceptable specified area of the template used for testing.Continuity testing was performed, the results were within specifications.Pressure testing was performed to identify any potential leak paths and confirmed that the parameters were within specifications.Flow testing was performed, the catheter was attached to a pump to test the saline flow, no anomalies were noted in all six irrigation ports; the catheter results were within specifications.Electrical testing was performed, the device was able to complete an ablation without any difficulties.Noise values were found typical and within specifications.Laboratory analysis was unable to confirm the reported clinical observations; the catheter passed all relevant testing.
 
Event Description
It was reported that during a procedure with a intellanav stablepoint ablation catheter, it was difficult to advance the tip of the catheter to the target site since the curve would bent on the proximal side.The catheter could not be positioned properly and the ablation effect could not be observed; the electrogram amplitude could not be decreased properly.The potential was not depleted, there was an easy re-conduction of the block line, and a dormant conduction has also occurred several times.This catheter was not replaced and the procedure was completed with the ablation unfinished.There were no patient complications.The product has been returned to boston scientific and a laboratory analysis has been completed.
 
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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 Key14690650
MDR Text Key294049376
Report Number2134265-2022-06814
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/27/2023
Device Lot Number0028277637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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