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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 0029189992
Device Problems Material Deformation (2976); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone (b)(6).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
It was reported that during the preparation of a procedure to treat an atrial tachycardia, an intellanav stablepoint open-irrigated catheter was selected for use.Nurse in the lab opened the package of the catheter.Physician took the catheter out and recognized that the tip of the catheter was bent and seemed to be broken.The tip was like swirled and over the edges.It was decided that it was too risky to use the catheter for this case.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter is expected to be returned for further analysis.
 
Manufacturer Narrative
Additional information: section d4: lot number 29189992, expiration date 06-apr-2024, serial number (b)(6), unique identifier (udi) (b)(4).Section g2: report source (other) germany.Section h4: device manufacture date: 07-apr-2022.Section e1: initial reporter phone (b)(6).Intellanav stablepoint open-irrigated catheter was evaluated by boston scientific.Visual inspection was performed, and no damages were observed on the returned device.Laboratory analysis was unable to confirm the reported clinical observations.Device was found within specifications.
 
Event Description
It was reported that during the preparation of a procedure to treat an atrial tachycardia, an intellanav stablepoint open-irrigated catheter was selected for use.Nurse in the lab opened the package of the catheter.Physician took the catheter out and recognized that the tip of the catheter was bent and seemed to be broken.The tip was like swirled and over the edges.It was decided that it was too risky to use the catheter for this case.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter has been returned for further 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 Key17032799
MDR Text Key316247803
Report Number2124215-2023-22280
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,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0029189992
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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