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

Model Number	M004R96200
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 11-dec-2018 it was reported that noise occurred.An intellanav open-irrigated catheter was selected for a premature ventricular contractions (pvc) ablation procedure.During ablation noise was observed on signals 1 and 2.No patient complications occurred.The procedure was completed with another nav oi.No patient complications were reported.However, returned device analysis revealed blocked irrigation ports.Visual inspection reveled dried body fluid also found on the handle and main body tubing as well as distal end and inside the irrigation ports.Dried saline found on the distal end and inside the irrigation ports.Electrical continuity checks revealed no electrical shorts or opens, as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.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.Ablation was verified by using a maestro generator 4000, a metriq pump, and a tank of 37c saline solution.However, occlusion errors occurred due to blocked irrigation ports, so ablations were performed on the bench without pump or saline.The device was found within specifications.

• 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: 8231423
• Report Number: 2134265-2018-64941
• Device Sequence Number: 1621228
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 05/13/2021
• Device Model Number: M004R96200
• Device Catalogue Number: 87045
• Device Lot Number: 0022112153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1