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

Model Number	87045
Medical Device Problem Codes	Failure to Deliver Energy (1211); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age: 18 years or older.The device was returned for analysis.Distal end was bent in two places (s-curve) approximately 43 and 66mm from the end of the distal tip.There was a rust color inside the butt bond gap under the adhesive seal.Dried body fluid was found on the handle, main body tubing, and distal end.Dried saline was found on the distal end and inside the irrigation ports.While manipulating the shaft, continuity checks revealed no electrical shorts or opens as checked manually using a multi-meter and breakout box.All electrodes, thermocouple and sensor 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.The device was connected to a maestro 4000 to measure tip temperature.During 5 minutes at room temperature (21.4c), the maestro displayed 22c.While soaking the distal end for 5 minutes in a tank of 37.0c saline, the maestro displayed 37c.Ablation could not be verified by using a maestro generator 4000, a metriq pump, and a tank of 37c saline solution due to occlusion errors on the pump screen.A syringe filled with saline was connected to the luer fitting.The plunger could not be depressed, and saline did not flow out of the irrigation ports.X-ray confirmed two bends in the distal end, and also found debris inside the distal cavity between rings 1 & 3.The distal end was dissected to further investigate the debris.Dry rust colored material was found on the end of the steering sheath.The lumen was isolated 15mm from the end of the distal tip.A syringe filled with saline was connected to the luer fitting.The plunger was depressed and saline easily flowed out of the end of lumen.
Event or Problem Description
It was reported that the catheter showed high temperatures.During an ablation procedure for atrial fibrillation in the right atrium, the temperature display of the intellanav open-irrigated catheter suddenly showed an abnormal value of 70 degrees celsius despite energization having already been performed sever times, and it became unable to further ablate.Power mode was used with irrigation settings at -2ml/min as it was not the timing of applying current and the catheter was irrigated at all times while inside the patient.The approach was made while making a curve using a deflectable sheath and the catheter got bent.The procedure was completed successfully by replacing the catheter, and no patient issues occurred.Device analysis revealed there was evidence of fluid ingress through a cracked butt bond seal.

• 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: 8871163
• Report Number: 2134265-2019-09411
• Device Sequence Number: 713259
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 11/27/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023001779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/07/2019
• Patient Sequence Number: 1