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

Model Number	87045
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection showed there was a gap in the butt bond.There was dried saline in the luer and dried body fluid on the shaft.Continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.All electrode/ thermocouple/magnetic sensor resistances measured in spec and were typical.The measurements were repeated in the right and left curve configuration and again, all measurements were within specifications and typical.Lcr test was performed and confirmed that the magnetic sensor was within specifications.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 using an isaac pressure decay test system.The lumen pressure decay was measured three times, starting with 107 psi, with re-seating of the tb seal between each test.Pressure decay values were 0.2241 psi, 0.1954 psi and 0.1867 psi.These values are within an acceptable limit.A slit in the distal end insulation tubing was made and dried saline crystals were visible in the interior of the shaft.
Event or Problem Description
Reportable based on device analysis completed on 11feb2020.It was reported that tracking/accuracy issues occurred.During an ablation procedure to treat atrial fibrillation, after successful mapping, an intellanav open-irrigated catheter was ablating in the femoral artery when they lost magnetic tracking.The catheter disappeared in rhythmia.The procedure was completed with a replacement device.No patient complications were reported.However, device analysis revealed the butt bond between the insulations of the distal and proximal shafts was compromised.

• 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: 9817368
• Report Number: 2134265-2020-02920
• Device Sequence Number: 1300032
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 02/04/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023297492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1