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

Model Number	87045
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter temperature was stuck at 20 degrees celsius.During an ablation procedure, when the intellanav open-irrigated catheter was inserted into the heart, the temperature was displayed at 20 degrees celsius, so the cable was replaced.The issue did not improve so the catheter was replaced, which resolved the issue.There were no adverse patient effects, and the procedure was completed successfully with the new catheter.
Event or Problem Description
It was reported that the catheter temperature was stuck at 20 degrees celsius.During an ablation procedure, when the intellanav open-irrigated catheter was inserted into the heart, the temperature was displayed at 20 degrees celsius, so the cable was replaced.The issue did not improve so the catheter was replaced, which resolved the issue.There were no adverse patient effects, and the procedure was completed successfully with the new catheter.
Additional Manufacturer Narrative
The device was returned for analysis.The device did not have any obvious visible defects.No opens or shorts in the tc or distal tip circuits in the dry condition.The distal tip electrode was wetted in saline.No observed shorts between the tc and distal tip after 1 minute of soaking.The lumen was then pumped with 30 ml/min saline using a metriq pump.Within seconds of pumping, a high resistance short between the tc and thermocouple circuits was identified.The resistance stabilized at ~400 k-ohms after 30 seconds of pumping.The device's lumen was leak tested using an isaac pressure decay test system.The lumen pressure decay was measured two times, starting with 107 psi, with re-seating of the tb seal between each test.Pressure decay values were 0.1214 psi and 0.1181 psi.This was within the acceptable limits.

• 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: 9090431
• Report Number: 2134265-2019-11428
• Device Sequence Number: 2597508
• Product Code: OAD
• UDI-Device Identifier: 08714729937456
• UDI-Public: 08714729937456
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 05/06/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023752427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1