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

Model Number 87045

Device Problems Power Conditioning Problem (1474); Impedance Problem (2950); Material Deformation (2976); Mechanics Altered (2984); Temperature Problem (3022); Data Problem (3196); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

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 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
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora,; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8821378
• MDR Text Key: 152031007
• Report Number: 2134265-2019-08661
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150005/S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAESTRO GENERATOR 4000; RHYTHMIA HDX MAPPING SYSTEM V. 3.0