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 Codes	Device Displays Incorrect Message (2591); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a ventricular tachycardia procedure an intellanav mifi open-irrigated catheter was selected for use.It was reported that at the start of radiofrequency (rf) delivery the maestro 4000 generator gave a "temperature too high error" and stopped delivering rf.At this time, it was discovered that the luer connection on the ablation catheter handle had detached from the catheter tubing that comes out of the catheter handle.The ablation catheter was replaced and the procedure was completed successfully with no patient complications.The device is expected to return for laboratory analysis.
Additional Manufacturer Narrative
Intellanav mifi open-irrigated catheter was evaluated by boston scientific.Visual inspection noted that the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint, consequently confirming the reported events.The probable cause of "cause traced to device design" will be assigned to this complaint since the problem found was traced to the design specification.
Event or Problem Description
It was reported that during a ventricular tachycardia procedure an intellanav mifi open-irrigated catheter was selected for use.It was reported that at the start of radiofrequency (rf) delivery the maestro 4000 generator gave a "temperature too high error" and stopped delivering rf.At this time, it was discovered that the luer connection on the ablation catheter handle had detached from the catheter tubing that comes out of the catheter handle.The ablation catheter was replaced and the procedure was completed successfully with no patient complications.The device has been received at boston scientific post market laboratory.

• 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: 18480163
• Report Number: 2124215-2023-75411
• Device Sequence Number: 6794610
• 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): 02/26/2024

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: 09/11/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0032408366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown