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 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

The intellanav mifi open-irrigated ablation catheter was returned to boston scientific for analysis.Visual inspection revealed the presence of a foreign material in the distal tip and around the mini-electrodes.Functional testing noted no abnormal resistance while maneuvering the catheter.Continuity tests were 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.Flow testing was performed, the catheter was attached to a pump to test the saline flow, the device resent a partial obstruction.Electrical testing was conducted and the device was able to complete a test ablation, but the noise values were found out of specifications.The results of the product analysis define the device pass the functional, leak, continuity tests, however in the electrical test, it was confirmed that the device had a significant noise and is out of the specifications.It was also noticed that the device had a foreign material in the irrigation holes and this issue could be affect the performance and capabilities of the device and cause the noise in the rhythmia mapping system.

Event Description

Reportable based on device analysis completed on 30 jun 2022.It was reported that during an ablation procedure with an intellanav mifi oi catheter to treat an atrial fibrillation condition in the atrium.During the procedure noise/low signal quality issues occurred.The catheter was replaced with another of the same model and the procedure was completed successfully without any patient complications.Device was returned for analysis.However, device analysis found foreign material around the mini electrodes.

• 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: 15094593
• MDR Text Key: 304136103
• Report Number: 2134265-2022-08128
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0028551651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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