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

Model Number	87045
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection revealed dried body fluid found on the handle, main body tubing, distal end.Dried saline on the distal end and inside several irrigation ports.Electrical tests revealed 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.Functional inspection revealed 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.Hdx testing revealed noise testing in ablation condition met current device specifications, where peak to peak values were less than 0.4 mv.Maximum values of ~ 0.05 mv peak to peak were observed in mifi 1-2 bipole.X-ray inspection found fluid inside the tip.Pressure leak test revealed the device's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst seal for sealing the irrigation holes and mes.The lumen pressure decay was measured three times, with re-seating of the tb seal between each test.Pressure decay values were 1.632, 1.605 and 1.589 psi, which were below the acceptable upper limit of 0.30 psi.The handle was dissected.No evidence of fluid leakage was found.Next, the distal end was dissected.Again, no evidence of fluid leakage was found.
Event or Problem Description
Reportable based on device analysis completed on 09dec2019.It was reported that noise appeared on the 1-2 potentials, and it disappeared.The intella nav oi was selected for a ablation procedure.After about 2 hours of use, noise suddenly appeared on the 1-2 potentials and disappeared.Cable was replaced, but noise and tracking did not improve.The ablation catheter was replaced, and ablation was completed successfully.However, analysis revealed that the device failed a lumen leak test, indicating a fluid leak inside the shaft.

• 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: 9557671
• Report Number: 2134265-2019-16487
• Device Sequence Number: 2245687
• 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): 01/07/2020

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 80