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

Model Number	87045
Medical Device Problem Codes	Improper Flow or Infusion (2954); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient irrigation flow from the catheter tip.During a percutaneous catheter myocardial ablation procedure, despite earlier performing at around 29-30 degrees celsius, the intellanav open-irrigated was persistently caught at the temperature limit of 42 degrees celsius during energization in power control mode.The flow rate setting was 17/30 ml/min and high flow setting over 31 watts.When checked, there was no thrombus adhered.The device was irrigated at all times while inside the patient.When flushing was performed by fast forward from the metriq pump, it was confirmed that water only came out of 5 holes.The procedure was completed with a second catheter, and there was no adverse effect to the patient.
Event or Problem Description
It was reported that there was insufficient irrigation flow from the catheter tip.During a percutaneous catheter myocardial ablation procedure, despite earlier performing at around 29-30 degrees celsius, the intellanav open-irrigated was persistently caught at the temperature limit of 42 degrees celsius during energization in power control mode.The flow rate setting was 17/30ml/min and high flow setting over 31 watts.When checked, there was no thrombus adhered.The device was irrigated at all times while inside the patient.When flushing was performed by fast forward from the metriq pump, it was confirmed that water only came out of 5 holes.The procedure was completed with a second catheter, and there was no adverse effect to the patient.
Additional Manufacturer Narrative
The device was returned for analysis.Dried body fluid was found on the handle, main body tubing, distal end.Dried saline was on the distal end and inside all irrigation ports.One irrigation port appeared partially blocked by excess solder inside the tip.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.A metriq pump and irrigation line with di water was connected to the device and then the distal end was suspended in the center of a 250ml beaker.The pump flow rate was set to 30ml/min (ablation rate) for 5 minutes.After 5 minutes, the beaker contained approximately 149ml of water, which was within spec.Device was soaked for 30 minutes, during which it went through multiple ablation/agitation cycles.No temperature issues occurred.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; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8866500
• Report Number: 2134265-2019-09333
• Device Sequence Number: 2390498
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 05/14/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023796521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR