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

Model Number	87045
Medical Device Problem Code	Power Conditioning Problem (1474)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
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 several irrigation ports.One irrigation port appeared partially blocked by excess solder inside the tip.While manipulating the shaft, continuity checks revealed no electrical opens as checked manually using a multi-meter and breakout box.Sensor 1 and sensor 2 to tip intermittently shorted with shaft movement.All other 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.X-ray found a knot in the sensor wires approximately 77cm from the end of the distal tip.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 150ml of water, which was within spec.The shaft was dissected to investigate the knot in the sensor wires.Both sensor wires had abraded insulation at the peak of the knot.Those abraded sections matched a section of abraded guide coils.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2019.It was reported that noise occurred.During a percutaneous catheter myocardial ablation, after preparation of the intellanav open-irrigated catheter was completed and it was inserted into the body, noise appeared while in the right inguinal.The procedure could not be performed with the catheter and the physician decided the device could not be used safely.A second catheter was unpacked, and because no noise appeared on the second catheter, it was used to complete the ablation procedure.The procedure was completed successfully and there were no adverse patient effects.However, device analysis revealed irrigation flowed through only 5 ports.

• 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: 9107285
• Report Number: 2134265-2019-11555
• Device Sequence Number: 11208330
• 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): 09/23/2019

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: 05/20/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023827713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1