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 Problems Poor Quality Image (1408); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(6) 2023.It was reported that the catheter exhibited high temperature and noise.During a left ventricular ablation procedure to treat ventricular tachycardia an intellanav mifi open-irrigated ablation catheter was selected for use.High temperature was shown on the maestro4000 generator, and there was electrical noise observed on the catheter electrogram channel.The generator was in power control mode at the time with the power set to 30w.The noise started upon insertion into the patient via the femoral artery.When the catheter was moved to the first ablation target noise appeared on the tip-ring1 and ring-tor-ring3 electrogram channels.When the button was pressed to start ablation, the error message for high temperature appeared on the maestro generator and the temperature for the catheter was shown at 43 degrees celsius.The noise was intermittent in nature.The catheter was also hard to manipulate when attempting to navigate in the left ventricle.The connection cable was replaced, but this did not resolve the issue.The catheter was then replaced with another of the same model and the procedure was completed.No patient complications were reported.The device has been returned for analysis.However, analysis of the returned device revealed lumen damage and a leak.

Manufacturer Narrative

The intellanav mifi open-irrigated ablation catheter was received at the boston scientific post market laboratory.Upon receipt at our post market quality assurance laboratory the device underwent a visual inspection, functional test, leakage test, dimensional test, continuity test, and dissection analysis.The visual inspection revealed a catheter shaft kink 2.5cm from the distal tip and at the start of the catheter shaft.No abnormal resistance was felt when actuating the steering mechanism during the functional test, the steering knob and the tension control knob functioned properly on both lock and unlock positions.The device lumen was leak tested using an isaac hd leak tester (pressure decay test system) and a touhy bourst seal for sealing the irrigation holes and mini electrodes.The lumen pressure decay was measured three times, and the unit failed the test as it presented with a leak due to the aforementioned shaft kink.The device passed the dimensional test as both the right and left curves reached the specified area of the template.No problems were detected by the continuity test.The noise test could not be performed due to a communication error.The device was destructively analyzed, and damage was observed on the dual lumen at the start of the shaft.Analysis confirmed the reported "generator "message - d07 temperature too high" allegation but did not confirm the "device noisy electrogram" allegation or the allegation of curve difficult to move/steer.The complaint is now reportable based on analysis of the device due to the kinks, lumen damage, and leak discovered.

• 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: 17712265
• MDR Text Key: 322979290
• Report Number: 2124215-2023-48702
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030959730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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