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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER Back to Search Results
Model Number 87048
Device Problems Thermal Decomposition of Device (1071); Positioning Problem (3009)
Patient Problem Tissue Damage (2104)
Event Date 09/21/2020
Event Type  Injury  
Event Description
It was reported that while performing cavo-tricuspid isthmus (cti) line ablation to treat typical flutter, using a short sheath and a intellanav mifi xp catheter, they had trouble finalizing bidirectional block.They had no issues seeing the signal they were trying to target, but they were unable to get the stability needed to get attenuation.The physician decided to switch to a ramp protocol and when he removed catheter, char and a small piece of cardiac tissue was noted on the tip.There was no change noted in the patient's vital signs, nor complications.No impedance rise was noticed.The generator was set to 60w/70c/300 ohms/120sec.They were running the irrigation at standard direction for use (dfu) rates and there was no interruption of flow.It was unknown how many ablations had been performed, and no temperature increase was noted.The procedure was completed successfully after a new catheter was inserted.The patient had no complications upon transfer out of the laboratory.The product has been returned to boston scientific and is pending analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed there was dried tissue on the distal tip including mini electrodes (mes).There was dried body fluids on the sheath.The device did not have any other obvious visible defects.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrodes/ thermistor/magnetic sensor resistances measured in spec and were typical.Lcr test was performed and confirmed that the magnetic sensor was within specifications.Functional inspection showed 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.Tip motion was evaluated against the curve template.Both right and left curves passed the specified template area.X-ray showed coil collapse in the handle strain relief area.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported that while performing cavo-tricuspid isthmus (cti) line ablation to treat typical flutter, using a short sheath and a intellanav mifi xp catheter, they had trouble finalizing bidirectional block.They had no issues seeing the signal they were trying to target, but they were unable to get the stability needed to get attenuation.The physician decided to switch to a ramp protocol and when he removed catheter, char and a small piece of cardiac tissue was noted on the tip.There was no change noted in the patient's vital signs, nor complications.No impedance rise was noticed.The generator was set to 60w/70c/300 ohms/120sec.They were running the irrigation at standard direction for use (dfu) rates and there was no interruption of flow.It was unknown how many ablations had been performed, and no temperature increase was noted.The procedure was completed successfully after a new catheter was inserted.The patient had no complications upon transfer out of the laboratory.The product has been returned to boston scientific and analysis completed.
 
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Brand Name
INTELLANAV MIFI XP
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 Key10696810
MDR Text Key211874068
Report Number2134265-2020-14376
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729885726
UDI-Public08714729885726
Combination Product (y/n)N
PMA/PMN Number
P020025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2023
Device Model Number87048
Device Catalogue Number87048
Device Lot Number0025117750
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received12/09/2020
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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