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

Model Number	87045
Medical Device Problem Codes	Power Conditioning Problem (1474); Impedance Problem (2950); Material Deformation (2976); Mechanics Altered (2984); Temperature Problem (3022); Data Problem (3196); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the effect of the ablation could not be observed.The patient underwent an ablation procedure for atrial fibrillation.Upon unpacking the intellanav oi ablation catheter it was observed to be kinked and when bending in both directions an audible crack was heard and the catheter did not bend far enough.During the procedure in the left atrium it was felt that though there was irrigation, the catheter temperature was unusually low at 21 degrees c, and the impedance seemed to change little; the effect of the ablation could not be felt.The device was in power control mode.Signal noise was also present, which was improved by improving the power supply around the equipment.Magnetic positioning allowed for small cardiac vein isolation and the procedure to be successfully completed without patient complications.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8821378
• Report Number: 2134265-2019-08661
• Device Sequence Number: 16853855
• 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): 07/24/2019

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: 12/04/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023035894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAESTRO GENERATOR 4000; RHYTHMIA HDX MAPPING SYSTEM V. 3.0