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 04/20/2022

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 15 jun 2022.It was reported that during an ablation procedure to treat ventricular tachycardia using an intellanav mifi open-irrigated catheter they encountered noise.They noted that noise occurred when ever the catheter was deflected.They exchanged the catheter and were able to complete the procedure without patient complications.The catheter was received for analysis at boston scientific's post market laboratory where foreign material was found on the tip of the catheter and around the irrigation holes.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first functionally tested and no issue was found with it's steering or maneuvering capabilities.They then tested the path of current flow through the catheter and the device was within specification for the continuity testing, however, during further electrical testing noise was present.During visual inspection for the cause of the noise they found foreign material around the mini electrodes.When an irrigation flow test was conducted the device failed and the same foreign matter was found in the irrigation holes at the catheter's tip.Investigation confirmed the allegation in the complaint as noise was present during testing.In addition the device failed irrigation testing and foreign material was found on the tip which may impact the efficacy of the catheter's irrigation system.

• 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: 14989095
• MDR Text Key: 304018243
• Report Number: 2134265-2022-07849
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0028324886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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