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

Model Number	M004R96200
Medical Device Problem Codes	Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed december 5th, 2018.An intellanav oi ablation catheter and a maestro generator were selected for us during an ablation procedure.The catheter failed to communicate properly with the generator.After mapping, attempts at delivering rf energy were unsuccessful due to the apparent communication fault.The generator either displayed temperature out-of-range errors, or "locating catheter" messages after several power cycles.The catheter was eventually replaced with a new catheter and the issue resolved.No patient complications occurred.However, returned device analysis revealed a gap at the butt bond and subsequent body fluid ingress.Visual inspection of the returned device revealed a gap between the distal and proximal shafts at the butt bond.The gap is slightly less than 1 mm wide, exposing the support sleeve under the shaft insulation.There is no visible evidence of adhesive on the support sleeve.A bead of adhesive was present and continuous around the circumference of both the distal and proximal shaft ends.There were two kinks located at approximately 3cm and 6cm from the distal end.There was dried body fluid on the support sleeve at the butt bond.Continuity checks revealed no electrical opens.In the right and left curve positions, as well as the neutral position, all the electrodes, thermocouple, resistor id, and magnetic sensor are shorted together.The steering knob and the tension control knob functioned properly in both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Ablation tests were not performed due to the breach at the butt bond.However, the catheter was connected to the generator and the generator was able to identify the catheter.X ray revealed a bent center support.The fluid ingress due to the gap at the butt bond is mostly likely the reason for the high temperature errors, as the thermocouple measurements are within specification.The measurements between the thermocouple, the magnetic sensor, and the electrodes are erratic, which is also most likely due to fluid ingress.

• 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: 8184384
• Report Number: 2134265-2018-64567
• Device Sequence Number: 2025702
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 08/31/2021
• Device Model Number: M004R96200
• Device Catalogue Number: 87045
• Device Lot Number: 0022596390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/20/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR: BOSTON SCIENTIFIC MAESTRO