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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2022
Event Type  malfunction  
Manufacturer Narrative
The intellanav mifi open-irrigated catheter was returned to boston scientific for analysis.Media inspection of a video attached to the complaint confirmed the reported noisy signals.Visual inspection of the returned device revealed a foreign material in the irrigation holes.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed and no problems were detected.The device's lumen was leak tested using an isaac hd leak tester (pressure decay test system) and a touhy bourst seal for sealing the irrigation holes and mini electrodes.The lumen pressure decay was measured three times.The unit passed the test without problems.The device was connected to a metriq pump and all six irrigation ports flow freely.The device was irrigated for 5 minutes without any errors or pump messages.The noise signals of the device were verified during an radiofrequency (rf) ablation test by using a maestro generator 4000 and a metriq irrigation pump connected to a rhythmia mapping system, the device was able to complete an rf ablation test.Noise values were found typical and within specifications.
 
Event Description
Reportable based on device analysis completed on (b)(6) 2022 during a ablation procedure to treat premature ventricular contractions a intellanav mifi open-irrigated catheter was selected for use.It was reported that all ekg and egm signals exhibited intermittent high frequency noise and magnetic tracking during ablation.The catheter was exchanged and the procedure was completed successfully with no patient complications.However, device analysis revealed a foreign material in the distal zone and in the irrigation holes.
 
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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 Key15006357
MDR Text Key304692002
Report Number2134265-2022-07878
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
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
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/21/2023
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0027882998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2022
Initial Date FDA Received07/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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