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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 Failure to Deliver Energy (1211); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2023
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
During a radiofrequency cardiac ablation procedure an intellanav mifi open-irrigated catheter was selected for use.It was reported that the catheter was unable to discharge.Additionally, it was reported that low temperature issue occurred.No error message occurred.The device was replaced, and the procedure was competed successfully without patient harm.The device is expected to be returned for analysis.
 
Event Description
During a radiofrequency cardiac ablation procedure an intellanav mifi open-irrigated catheter was selected for use.It was reported that the catheter was unable to discharge.Additionally, it was reported that low temperature issue occurred.No error message occurred.The device was replaced, and the procedure was competed successfully without patient harm.The device is expected to be returned for analysis.
 
Manufacturer Narrative
Intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Analysis of device did not find any evidence or defect that could have contributed to the reported event.The device does not have visual defects.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 device 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 was purged at 60 ml/min.All six irrigation ports flow freely.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.Electrical continuity testing was performed and no problems were detected.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.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.
 
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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 Key17686048
MDR Text Key322673110
Report Number2124215-2023-47388
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P150005/S017
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 10/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2023
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 Number0029648173
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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