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 Contamination with Chemical or Other Material (2944)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

The intellanav mifi open-irrigated catheter was returned to boston scientific for analysis.Media inspection of a video attached to the complaint confirmed the reported noisy signals.Visual inspection of the returned device revealed a foreign material in the irrigation holes.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.The continuity test was performed and no problems were detected.The device's 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.The unit passed the test without problems.The device was connected to a metriq pump and all six irrigation ports flow freely.The device was irrigated for 5 minutes without any errors or pump messages.The noise signals of the device were verified during an radiofrequency (rf) ablation test by using a maestro generator 4000 and a metriq irrigation pump connected to a rhythmia mapping system, the device was able to complete an rf ablation test.Noise values were found typical and within specifications.

Event Description

Reportable based on device analysis completed on (b)(6) 2022 during a ablation procedure to treat premature ventricular contractions a intellanav mifi open-irrigated catheter was selected for use.It was reported that all ekg and egm signals exhibited intermittent high frequency noise and magnetic tracking during ablation.The catheter was exchanged and the procedure was completed successfully with no patient complications.However, device analysis revealed a foreign material in the distal zone and in the irrigation holes.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• 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: 15006357
• MDR Text Key: 304692002
• Report Number: 2134265-2022-07878
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027882998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1