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

Model Number 87047

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The returned device was reported for high impedance.Visual inspection of the returned device showed that device does not have any obvious visible defects.There is dried saline on the sheath and tip.There are bodily fluids on the sheath and tip.During electrical testing all electrode/ thermocouple/magnetic sensor resistances measured in spec.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The devices was dissected and a leak was found in the handle where the blue irrigation lumen and clear extension tubing are joined together.

Event Description

Reportable based on analysis completed on 09oct2020.It was reported that a intellanav mifi open-irrigated ablation catheter was used in a ablation procedure.The local impedance value were around 300 and could not reach normal values.The catheter was replaced and the procedure was completed with no patient complications being reported.However analysis of the device revealed a leak in the handle.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 10792934
• MDR Text Key: 214811363
• Report Number: 2134265-2020-15394
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024826934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1