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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI
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BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI Back to Search Results
Model Number 87045
Device Problems Material Perforation (2205); Improper Flow or Infusion (2954); Material Deformation (2976); Positioning Problem (3009); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
Patient age: 18 years or older.
 
Event Description
It was reported that the catheter tip was kinked, irrigation was insufficient, temperature increased, and the proximal membrane was torn.During an ablation procedure for atrial fibrillation in the left and right atrium, it was noticed that the intellanav open-irrigated catheter's tip shaft was kinked.The physician judged that it could still be used and continued with the procedure.The irrigation settings were 17ml/min in power control mode.The catheter was irrigated at all times while inside the patient.The temperature increased when energization was performed in the coronary sinus (cs), and ablation was unable to continue.When inserting the catheter into the cs, manipulation became difficult.The device was removed from the body, and when checked, the twisting of the tip shaft had become worse than when it was inserted, and the flow of the irrigation was worse as well.Moreover, since the proximal membrane was slightly torn, the catheter was replaced with a non-boston scientific device.The procedure was completed, and no patient complications occurred.
 
Manufacturer Narrative
Patient age: 18 years or older.The device was returned for analysis.Distal end was severely twisted.Butt bond seal was damaged creating a wide gap between proximal and distal sections.Dried body fluid was found inside the butt bond gap, on the handle, main shaft and distal end.Dried saline was on the distal end and inside several irrigation ports.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.
 
Event Description
It was reported that the catheter tip was kinked, irrigation was insufficient, temperature increased, and the proximal membrane was torn.During an ablation procedure for atrial fibrillation in the left and right atrium, it was noticed that the intellanav open-irrigated catheter's tip shaft was kinked.The physician judged that it could still be used and continued with the procedure.The irrigation settings were 17ml/min in power control mode.The catheter was irrigated at all times while inside the patient.The temperature increased when energization was performed in the coronary sinus (cs), and ablation was unable to continue.When inserting the catheter into the cs, manipulation became difficult.The device was removed from the body, and when checked, the twisting of the tip shaft had become worse than when it was inserted, and the flow of the irrigation was worse as well.Moreover, since the proximal membrane was slightly torn, the catheter was replaced with a non-boston scientific device.The procedure was completed, and no patient complications occurred.
 
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Brand Name
INTELLANAV OPEN-IRRIGATED
Type of Device
INTELLANAV OI
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key8871142
MDR Text Key153711409
Report Number2134265-2019-09404
Device Sequence Number1
Product Code OAD
UDI-Device Identifier08714729937432
UDI-Public08714729937432
Combination Product (y/n)N
PMA/PMN Number
P150005/S005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/20/2022
Device Model Number87045
Device Catalogue Number87045
Device Lot Number0023827713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Date Manufacturer Received08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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