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 High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

The reported failure was confirmed through investigation analysis.Visual inspection found died body fluid on the handle, main body tubing, and distal end.Dried saline was also noted on the distal end and inside irrigation ports.Electrical tests revealed no shorts and all other electrodes, sensor and thermocouple resistances measured in spec and were typical.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.X-ray inspection revealed no abnormalities.A lumen leak test was performed which the device failed.This indicates a fluid leak inside the shaft.Fluid inside the distal end cavity can cause electrical issues.

Event Description

Reportable based on device analysis completed on december 09 2019.It was reported that high impedance values were observed.During a cavotricuspid isthmus ablation with a intellanav mifi open-irrigated catheter, high impedance values were observed when the catheter was removed from the patient in order to perform a validation map.After the catheter was re-introduced into the patient, high impedances values were still noted.The procedure was completed with another ablation catheter.No patient complications were reported and the patient's current condition is fine.However, returned device analysis revealed a fluid leak inside the shaft.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 9557838
• MDR Text Key: 177598583
• Report Number: 2134265-2019-16489
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938378
• UDI-Public: 08714729938378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0022932541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1