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

Model Number	M004PMR96200
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During radiofrequency ablation of atrial fibrillation procedure, a intellanav mifi open-irrigated catheter was selected for use.It was reported that the temperature sensor of the device was damaged, and the temperature of the device in the body was abnormal.No error message was displayed.The device has been replaced and the procedure was completed successfully with no patient complications.The device will be returned for analysis.
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.
Additional Manufacturer Narrative
The intellanav mifi open-irrigated catheter was evaluated by boston scientific.Upon receipt at our post market quality assurance laboratory, the device was visually inspected and showed no abnormalities.Functional test shows that the catheter functional mechanism worked properly.No abnormal resistance was felt when actuating the device.The device lumen was leak tested; the lumen pressure decay was measured three times.The unit passed the test without problems.The device was connected to a metriq pump and was purged at 60 ml/min.All six irrigation ports flow freely.The pump was programmed to 30ml/min and the device was irrigated for 5 minutes without any errors or pump messages.Continuity, electrical and rf ablation tests were performed and the device was found within specifications.Laboratory analysis was unable to confirm the reported clinical observation of poor temperature control.Device functioned as intended.
Event or Problem Description
During radiofrequency ablation of atrial fibrillation procedure, a intellanav mifi open-irrigated catheter was selected for use.It was reported that the temperature sensor of the device was damaged, and the temperature of the device in the body was abnormal.No error message was displayed.The device has been replaced and the procedure was completed successfully with no patient complications.The device was 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20643385
• Report Number: 2124215-2024-70434
• Device Sequence Number: 7443408
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: 10/03/2025
• Device Model Number: M004PMR96200
• Device Catalogue Number: M004PMR96200
• Device Lot Number: 0032569332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown