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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 Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2020
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
It was reported that during a redo ablation procedure to treat atrial fibrillation, the intellanav mifi open-irrigated catheter was functioning normally, however after about 30 minutes, the temperature was showing 53 degrees celsius.The catheter was then replaced with another of the same device and the procedure was completed.No patient complications occurred.The device is expected to be returned for analysis.
 
Event Description
It was reported that during a redo ablation procedure to treat atrial fibrillation, the intellanav mifi open-irrigated catheter was functioning normally, however after about 30 minutes, the temperature was showing 53 degrees celsius.The catheter was then replaced with another of the same device and the procedure was completed.No patient complications occurred.The device has been returned for analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed the device did not have any obvious visible defects.There was saline in the luer and tip.There was dried bodily fluids on the luer, handle, shaft and tip.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical.Lcr (inductance (l), capacitance (c), and resistance (r) test was performed and confirmed that the magnetic sensor was within specifications, but lcr resistance changed from being measured with the fluke multimeter.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's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst seal for sealing the irrigation holes and me's (mini electrodes).The lumen pressure decay was measured three times.Lumen pressure decay values were 0.2081 psi, 0.1761 psi, and 0.1644 psi, which were below the maximum acceptable limit of 0.30 psi.The handle was opened.The smaller piece of foreign material noted on the x-rays is a fragment of a signal wire which is adhered to the flex between the sensor and thermocouple solder joints.The larger piece of foreign material was not recovered.No other anomalies were noted in the handle.Measurements between the thermocouple and the tip and all rings showed a resistive short.(2-3mohms).Closer visual examination of the rings revealed potential areas of compromised seals on both ring 1 and ring 3.The distal shaft was dissected.Dried body fluid is present in the interior of the shaft with the greater concentrations near ring 3 and tapering off going toward the butt bond.No dried saline was noted.Two twists in the thermocouple wire were noted.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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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 Key10944260
MDR Text Key219488994
Report Number2134265-2020-16925
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729938361
UDI-Public08714729938361
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 02/23/2021
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 Date01/29/2022
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0025130311
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Initial Date Manufacturer Received 11/13/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received02/10/2021
Supplement Dates FDA Received02/23/2021
Patient Sequence Number1
Patient Age48 YR
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