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	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was reported for noisy electrodes.Visual inspection of the device revealed dried saline and body fluids on the handle and shaft.Functional inspection shoed that no abnormal resistance was felt when actuating the steering mechanism.Dissection of the handle showed there is evidence of minor fluid ingress in the distal end of the handle and corrosion is present on the guide coil and residue is present on the interior of the handle.During the leak isolation test two leaks were evident approximately 39.5cm and 91 cm from distal tip.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.
Event or Problem Description
It was reported that a intellanav open-irrigated was used in a atrial tachycardia procedure.It was noted that during the procedure noisy electrodes occurred.The procedure was completed using a different device with no patient complications being reported.However analysis of the returned device revealed two leaks.

• 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: 10594080
• Report Number: 2134265-2020-13420
• Device Sequence Number: 19120650
• Product Code: OAD
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 08/15/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0024279244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1