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

Model Number	87045
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination revealed a piece of the ring 2 seal missing.There is dried saline and body fluids on the handle and shaft.Electrical 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.The steering knob and the tension control knob functioned properly on both lock and unlock positions.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 0.1260 psi, 0.1101 psi, and 0.1013 psi.These values are within the acceptable range.X-rays showed evidence of fluid ingress in the distal end between rings 1 and 3.The distal end was opened proximal to ring 3.Saline crystals were noted on several of the signal wires confirming the fluid ingress.Fluid ingress is known to affect signal and thermocouple integrity and is the most likely reason for the temperature and tracking issues reported by the field.
Event or Problem Description
Reportable based on analysis completed on 23dec2019.A intellanav oi ablation catheter was selected for a ablation procedure.However during the procedure the catheter disappeared from the system and the generator displayed "finding catheter" error and the temperature disappeared.The procedure was completed using a different catheter which resolved the issue with no patient complications being reported.However, returned device analysis revealed damaged ring seals.

• 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: 9595850
• Report Number: 2134265-2020-00183
• Device Sequence Number: 17009618
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005
• 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): 01/16/2020

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: 05/13/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023789199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1