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	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter had insufficient irrigation flow.Prior to a procedure to treat ventricular tachycardia (vt) an intellanav mifi open-irrigated catheter was selected for use.During setup of the catheter, it was noted that insufficient flow was coming out of the catheter during flushing.The flow rate was 60ml/min.The catheter was replaced with another of the same model.The procedure was completed with no patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The intellanav mifi open-irrigated catheter was returned to boston scientific for laboratory analysis.The returned catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.A media inspection of a customer attached video was conducted.It was not possible to identify any failures reported by the custumer, as the video was not clear enough.A visual inspection did not find any device defects.A functional test was performed, and the steering knob and the tension control knob functioned properly in both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Pressure testing was performed to identify any potential leaks.The catheter passed the leakage test with no problems.During a flow test, the device was connected to an external pump and was purged at 60 ml/min.All six irrigation ports flowed freely.The pump was then programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.Laboratory analysis was unable to confirm the reported clinical observation, the catheter passed all relevant testing.
Event or Problem Description
It was reported that prior to a procedure to treat ventricular tachycardia (vt) an intellanav mifi open-irrigated catheter was selected for use.During setup of the catheter, it was noted that insufficient flow was coming out of the catheter during flushing.The flow rate was 60ml/min.The catheter was replaced with another of the same model.The procedure was completed with no patient complications.The device is expected to be returned for analysis.

• 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: 16845406
• Report Number: 2124215-2023-16086
• Device Sequence Number: 7516059
• 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): 06/14/2023

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: 01/25/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030927955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown