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 Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Event Description

It was reported that after about an hour into an ablation procedure with an intellanav mifi open-irrigated ablation catheter, after the catheter was inserted into the body and energization was attempted, the temperature was displayed at approximately 80 degrees celsius.No error message related to the high temperature was displayed and the issue was persistent.First replacement of the cable was attempted, but the issue persisted.The procedure was completed with another mifi oi ablation catheter.No patient complications occurred, and the patient's condition was good.The device has been returned to boston scientific and is pending analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the device revealed that the main shaft of the tubing was torn open near the butt bond and that there was fluid ingress at the site of the fracture.Electrical testing found that all electrode, thermocouple, and magnetic readings were within acceptable specifications.Next, functional testing was performed and no the steering mechanism and tension control functioned properly.Finally a pressure leak test was performed and the lumen pressure decay were found to be below the maximum acceptable psi limit.The reported failure was confirmed through product analysis a fluid ingress can impact the performance of the temperature readings of the device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that after about an hour into an ablation procedure with an intellanav mifi open-irrigated ablation catheter, after the catheter was inserted into the body and energization was attempted, the temperature was displayed at approximately 80 degrees celsius.No error message related to the high temperature was displayed and the issue was persistent.First replacement of the cable was attempted, but the issue persisted.The procedure was completed with another mifi oi ablation catheter.No patient complications occurred, and the patient's condition was good.The device has been returned to boston scientific for analysis.

• 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
• MDR Report Key: 11060235
• MDR Text Key: 223398929
• Report Number: 2134265-2020-18373
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0025383926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1