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 Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that during a percutaneous myocardial ablation procedure in the left atrium, an intellanav mifi oi catheter was selected for use.During the procedure there was noise recorded on the rhythmia hdx mapping system for all electrodes, and the catheter could no longer be tracked in the system.As a result, this catheter was replaced and the issue was resolved.The procedure was completed without any patient complications.The catheter has been returned for laboratory analysis.However, device analysis found a foreign material around the mini electrodes.

Manufacturer Narrative

The intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection revealed a foreign material around the mini electrodes.Functional testing noted no abnormal resistance while maneuvering the catheter.Continuity testing was performed and the results were within specifications.Pressure testing was performed to identify any potential leak paths and confirmed that the parameters were within specifications.Functional testing was performed with the catheter attached to an external pump to determine saline flow.No error messages were triggered during testing, however, there was a partial obstruction in some of the irrigations holes.Electrical testing was conducted, results revealed that the noise values were found within specifications.Laboratory analysis was unable to confirm the reported clinical observations regarding the catheter not being recognized or the noise issues.

• 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: 15006248
• MDR Text Key: 302484511
• Report Number: 2134265-2022-07876
• 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: Foreign,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: 08/31/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0027941959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1