MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	87045
Medical Device Problem Codes	Material Perforation (2205); Improper Flow or Infusion (2954); Material Deformation (2976); Positioning Problem (3009); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age: 18 years or older.
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8871142
• Report Number: 2134265-2019-09404
• Device Sequence Number: 3294901
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023827713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1