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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 Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Event Description
It was reported that during an ablation procedure using an intellanav mifi open-irrigated catheter they had difficulty deflecting the catheter and when they removed the catheter to examine it they found the outer covering of the catheter was compromised.They replaced the catheter and were able to complete the procedure without any patient complications.The catheter has been received at boston scientific and is awaiting analysis.
 
Event Description
It was reported that during an ablation procedure using an intellanav mifi open-irrigated catheter they had difficulty deflecting the catheter and when they removed the catheter to examine it they found the outer covering of the catheter was compromised.They replaced the catheter and were able to complete the procedure without any patient complications.The catheter has been received at boston scientific for analysis.
 
Manufacturer Narrative
The catheter was received at boston scientific's post market laboratory for examination.Upon receipt visual inspection found the main shaft tubing was kinked and torn open near the butt bond.When examined under x-ray it was found the magnetic sensor wire was kinked and the guide coil had collapsed.There was evidence of fluid ingress at the site of the fracture.Next the function of the catheter's curve was tested, finding that the left curve failed to reach the full curve.When the steering knob and tension control were tested they were found to function properly and no abnormal resistance was found.Then the catheter was tested electrically, and all electrode and thermocouple measurements were found to be in specifications.This was also the case when the tests were repeated with the catheter in both the right and left curve configurations.Finally the catheter was pressure tested for leaks and it was found the pressure decay values were within the acceptable limit.The reported allegation was confirmed through device analysis.The main shaft was severely kinked which caused a breach in the outer layer of the catheter shaft.
 
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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
MDR Report Key11878420
MDR Text Key252926974
Report Number2134265-2021-06758
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938378
UDI-Public08714729938378
Combination Product (y/n)N
PMA/PMN Number
P150005/S017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2022
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0026369941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Date Manufacturer Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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