MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87047

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation procedure, an intellanav mifi open-irrigated catheter was selected for use.During the ablation procedure, an excessive temperature warning occurred on the maestro ablation generator at the start of ablation.It was noted that the irrigation tubing on the ablation catheter was leaking fluid, which caused the temperature error.It is suspected that the catheter tubing was kinked which caused the leak to occur.The catheter was replaced, and procedure was completed with no patient complications reported.The device is expected to return for laboratory analysis.

Manufacturer Narrative

The device was not received for analysis; however, a picture of the issue was provided.Visual inspection of the picture confirmed the irrigation tubing was partially detached from the luer fitting.The allegation of damaged irrigation tubing was confirmed.The cause of the issue was determined to be traced to device design as ultimately this issue traces back to the specifications of the design.

Manufacturer Narrative

Intellanav mifi open-irrigated was evaluated by boston scientific.Visual inspection noted that the irrigation extension tubing was found totally detached/separated from the luer fitting at the adhesive joint.No more damages were observed.The reported complaint is confirmed.Also, the reported catheter shaft "kinked" is not confirmed since no damages were observed on the catheter shaft.

Event Description

During an afib ablation procedure, an intellanav mifi oi 7.5/110/2.5/4.5 std was selected for use.It was reported that during the ablation procedure, an excessive temp warning occurred on the maestro ablation generator at the start of ablation.It was noted that the irrigation tubing on the ablation catheter was leaking fluid, which caused the temperature error.It is suspected that the catheter tubing was kinked which caused the leak to occur.The catheter was replaced, and procedure was completed with no patient complications reported.The device has been received at boston scientific post market laboratory.

• 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: 18518664
• MDR Text Key: 333007218
• Report Number: 2124215-2024-01197
• Device Sequence Number: 1
• Product Code: OAD
• 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,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0032527039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White