MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87047

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Nerve Damage (1979)

Event Date 04/11/2019

Event Type  Injury  

Event Description

It was reported that nerve damage occurred.During an pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation (af), an intellanav mifi open-irrigated catheter was selected for use.While the ablation was being performed in the right superior pulmonary vein, the patient experience partial phrenic nerve palsy.This was a complication due to the fact that the anatomy of the heart was a little bit unusual.When the doctor checked for the phrenic nerve activity, after ablating in the left atrium (la), there was no activity on the right sided nerve.It was also reported that the catheter magnetic sensor broke.While attempting to ablate the right inferior pulmonary vein, the ablation catheter disappeared from the map.They checked for any interference, there was none, so replaced ablation catheter and the procedure was completed.There were no other adverse events.

Manufacturer Narrative

The device was returned for analysis.Dried body fluid was found on the handle, main body tubing, distal end.Dried saline was on the distal end and inside the irrigation ports.While manipulating the shaft, continuity checks revealed no electrical shorts or opens as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.Lcr test was performed and the magnetic sensor was within specification.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.No tracking issues were observed.Device tested in all curve configurations, with numerous torqueing maneuvers.Two 60 sec 50w ablations performed during curving and torqueing did not elicit any abnormal tracking behavior.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that nerve damage occurred.During an pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation (af), an intellanav mifi open-irrigated catheter was selected for use.While the ablation was being performed in the right superior pulmonary vein, the patient experience partial phrenic nerve palsy.This was a complication due to the fact that the anatomy of the heart was a little bit unusual.When the doctor checked for the phrenic nerve activity, after ablating in the left atrium (la), there was no activity on the right sided nerve.It was also reported that the catheter magnetic sensor broke.While attempting to ablate the right inferior pulmonary vein, the ablation catheter disappeared from the map.They checked for any interference, there was none, so replaced ablation catheter and the procedure was completed.There were no other adverse events.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8574459
• MDR Text Key: 143858147
• Report Number: 2134265-2019-04783
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0023199772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other