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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87047
Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2023
Event Type  malfunction  
Event Description
It was reported that the tubing set was fractured and leaking fluid.It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.Metriq pump and maestro 4000 generator were in use.17ml/min was the flow rate.After 6 minutes of ablation, the generator alarmed excessive temperature.The luer lock port on the catheter was noted to be fractured and leaking fluid.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
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.
 
Manufacturer Narrative
Intellanav mifi open-irrigated catheter was evaluated by boston scientific.During product analysis and media inspection, it was observed the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint.Therefore, the reported clinical observations of tubing set- damaged defective, fluid leak and excessive temperature were able to be confirmed through laboratory analysis.
 
Event Description
It was reported that the tubing set was fractured and leaking fluid.It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.Metriq pump and maestro 4000 generator were in use.17ml/min was the flow rate.After 6 minutes of ablation, the generator alarmed excessive temperature.The luer lock port on the catheter was noted to be fractured and leaking fluid.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.
 
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Brand Name
INTELLANAV MIFI OPEN-IRRIGATED
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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 Key18296744
MDR Text Key330259786
Report Number2124215-2023-69337
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938385
UDI-Public08714729938385
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150005/S017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0032408366
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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