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

Model Number	87047
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.After approximately 10 minutes of use, it was found that fluid was leaking from the luer connection on the proximal end of the catheter.No error messages were displayed.The maestro flow rate was 17ml/min.The catheter was replaced, and the issue was resolved.The procedure was able to be completed successfully without any patient complications.The catheter has been received for analysis.
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.After approximately 10 minutes of use, it was found that fluid was leaking from the luer connection on the proximal end of the catheter.No error messages were displayed.The catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter was returned for laboratory analysis.
Additional Manufacturer Narrative
The intellanav mifi open-irrigated catheter was evaluated by boston scientific.Visual analysis of returned product revealed that the device has the irrigation tube partially detached, consequently confirming the reported allegation of tubing set fluid leak.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Common Device Name: 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: 19082395
• Report Number: 2124215-2024-21358
• Device Sequence Number: 7621066
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: 08714729938385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0032487797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown