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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 0030335252
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
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 catheter was selected for use during the pulmonary vein isolation procedure.It was reported that during preparation the side port was found damaged and was leaking.Due to this the catheter's electrical connection cable got wet.A different device was used to complete the procedure.No patient complications occurred.The device is expected to be returned for analysis.
 
Manufacturer Narrative
The intellanav stablepoint open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection revealed the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint, consequently confirming the reported event.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
 
Event Description
The intellanav stablepoint catheter was selected for use during the pulmonary vein isolation procedure.It was reported that during preparation the side port was found damaged and was leaking.Due to this the catheter's electrical connection cable got wet.A different device was used to complete the procedure.No patient complications occurred.The device was 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 Key16934512
MDR Text Key315284309
Report Number2124215-2023-22887
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0030335252
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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