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

Model Number	87045
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was sensing temperature lower than expected.During an ablation procedure for typical flutter, the physician inserted the intellanav open-irrigated catheter into the chamber.Distal temperature was about 31-32 degree celsius without ablation.With ablation energy on at 30 watts in power control mode, the temperature was about 19-20 degree celsius.The pump flow setting was 25-30 ml/min.The temperature sensor was under detecting.No error codes were displayed.No patient complications occurred.The procedure was completed with a new catheter.
Event or Problem Description
It was reported that the catheter was sensing temperature lower than expected.During an ablation procedure for typical flutter, the physician inserted the intellanav open-irrigated catheter into the chamber.Distal temperature was about 31-32 degree celsius without ablation.With ablation energy on at 30 watts in power control mode, the temperature was about 19-20 degree celsius.The pump flow setting was 25-30 ml/min.The temperature sensor was under detecting.No error codes were displayed.No patient complications occurred.The procedure was completed with a new catheter.
Additional Manufacturer Narrative
The device was returned to boston scientific for evaluation.Visual inspection found dried body fluid found on the handle, main shaft and distal end.Dried saline was also found on distal end and inside several irrigation ports.While manipulating the shaft, continuity checks revealed no electrical opens or shorts, 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.The device's lumen was leak tested, and the lumen pressure decay values were 0.1192, 0.1123 and 0.1104 psi, which are below the maximum limit of 0.3 psi.A metriq pump was connected to the device and the distal end was suspended in the center of a 250ml beaker.After 5 minutes at a flow rate of 30ml/min (ablation rate), the beaker contained approximately 145 ml of di water, which was within specifications.The device was connected to arhythmia hdx system, maestro 4000 generator and metriq pump in the laboratory.At room temperature (21.6c), the maestro displayed 22c.With the distal end submersed in the center of a tank of 37c saline, the maestro displayed 37c.At 2ml/min pump speed, the temperature displayed was 31-32c, which is typical.Next, three 30w, 60 second ablations at 30ml/min flow rate were performed.The device functioned normally with typical temperature readings (29-31c).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9865995
• Report Number: 2134265-2020-03692
• Device Sequence Number: 526329
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 05/28/2020

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: 06/23/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023992720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1