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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 Noise, Audible (3273)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 06/18/2020
Event Type  Injury  
Event Description
It was reported the patient experienced a cardiac tamponade a pericardial effusion.During an ablation procedure with an intellanav mifi open-irrigated catheter, right atrial mapping was performed with rhythmia and the catheter post cryo ablation (with non-boston scientific devices).Ablation of the slow pathway for av-nodal reentrant tachycardia (avnrt) was performed with the intellanav mifi oi through a non-boston scientific steerable sheath.Upon completion of the avnrt ablation, a non-boston scientific pacemaker right ventricle (rv) lead was deemed to interfere with planned cavo-tricuspid isthmus (cti) ablation.The intellanav mifi oi was removed from the sheath.Additional access obtained for another non-boston scientific sheath.An intellanav st std was placed through the first sheath to move the rv lead to the side.The intellanav mifi oi was reintroduced into the right atrium (ra) through the second sheath to begin ablation of the cti.Eventually, during ablation of the cti, a steam pop was observed during a 50watt burn at 30ml flow rate.Five additional ablation lesions were delivered before the anesthesiologist told the electrophysiologist (ep) that the patient's blood pressure was low.The ep immediately halted radiofrequency (rf) delivery and performed an intracardiac echocardiogram which showed an acute pericardial effusion.The pericardium was accessed and a pericardiocentesis was performed.The effusion eventually resolved and the patient was not sent to surgery.The physician attributed the event to the intellanav mifi oi catheter as it was ablating at 50w in that location for a long duration.No resistance was felt while maneuvering the catheters.It was noted that there was a singular spike on the local impedance graph on the raw tracing (white) not filtered tracing.The device will be returned for analysis.
 
Manufacturer Narrative
The device was returned to boston scientific for evaluation.Visual inspection showed blood stains on the main shaft and handle and the mifi electrode seal was broken.Tip motion was evaluated against a curve template.The right and left curves appeared normal and both curves reached the specified areas on the template.An ablation test showed the device ablated without any issues or abnormalities.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 toughly burst seal for sealing the irrigation holes and mini electrodes.The lumen pressure decay was measured three times, with re-seating of the tb seal between each test.Lumen pressure decay values were 0.1494, 0.1216 and 0.0908 pounds per square inch (psi), which were below the maximum acceptable limit of 0.30 psi.The distal tip electrode was immersed in 0.45% saline for 30 minutes.Tc+ and tc- to tip resistance measurements remained open.Next, the device was connected to a metriq pump.After irrigating for approximately 30 minutes at a flow rate of 30 ml/min, tc+ and tc- to tip resistance measurements remained open.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
It was reported the patient experienced a cardiac tamponade a pericardial effusion.During an ablation procedure with an intellanav mifi open-irrigated catheter, right atrial mapping was performed with rhythmia and the catheter post cryo ablation (with non-boston scientific devices).Ablation of the slow pathway for av-nodal reentrant tachycardia (avnrt) was performed with the intellanav mifi oi through a non-boston scientific steerable sheath.Upon completion of the avnrt ablation, a non-boston scientific pacemaker right ventricle (rv) lead was deemed to interfere with planned cavo-tricuspid isthmus (cti) ablation.The intellanav mifi oi was removed from the sheath.Additional access obtained for another non-boston scientific sheath.An intellanav st std was placed through the first sheath to move the rv lead to the side.The intellanav mifi oi was reintroduced into the right atrium (ra) through the second sheath to begin ablation of the cti.Eventually, during ablation of the cti, a steam pop was observed during a 50watt burn at 30ml flow rate.Five additional ablation lesions were delivered before the anesthesiologist told the electrophysiologist (ep) that the patient's blood pressure was low.The ep immediately halted radiofrequency (rf) delivery and performed an intracardiac echocardiogram which showed an acute pericardial effusion.The pericardium was accessed and a pericardiocentesis was performed.The effusion eventually resolved and the patient was not sent to surgery.The physician attributed the event to the intellanav mifi oi catheter as it was ablating at 50w in that location for a long duration.No resistance was felt while maneuvering the catheters.It was noted that there was a singular spike on the local impedance graph on the raw tracing (white) not filtered tracing.The device will be returned for analysis.
 
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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 Key10250918
MDR Text Key198125509
Report Number2134265-2020-09118
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 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/23/2021
Device Model Number87047
Device Catalogue Number87047
Device Lot Number0023239003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received07/28/2020
Patient Sequence Number1
Treatment
ABBOTT AGILIS SHEATH; ABBOTT AGILIS SHEATH; DYNAMIC XT DECAPOLAR; DYNAMIC XT DECAPOLAR; INTELLANAV ST; INTELLANAV ST; MEDTRONIC FLEXCATH; MEDTRONIC FLEXCATH; ABBOTT AGILIS SHEATH; DYNAMIC XT DECAPOLAR; INTELLANAV ST; MEDTRONIC FLEXCATH
Patient Outcome(s) Required Intervention;
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