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	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radio frequency ablation procedure to treat a supraventricular tachycardia (svt), an intellanav mifi open-irrigated catheter was selected for use.The magnetic sensor of the catheter might have been damaged, on the system the catheter image was abnormal, the signal was unstable and finally was lost, no error messages were displayed.Procedure was unable to be completed due to this event and had to be cancelled/rescheduled.No patient complications were reported.Device is expected to be returned for further 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
Intellanav mifi open-irrigated catheter was evaluated by boston scientific.Upon receipt at our post market quality assurance laboratory, catheter was inspected.Device passed all tests performed and analysis did not reveal any fault condition within the product that could have caused the system tracking issues seen in the field that led to the procedure cancellation.However, as a part of an additional finding, the device was destructively analyzed, and it was found an obstruction in the tip due to fluids and materials present during the procedure.
Event or Problem Description
It was reported that during a radio frequency ablation procedure to treat a supraventricular tachycardia (svt), an intellanav mifi open-irrigated catheter was selected for use.The magnetic sensor of the catheter might have been damaged, on the system the catheter image was abnormal, the signal was unstable and finally was lost, no error messages were displayed.Procedure was unable to be completed due to this event and had to be cancelled/rescheduled.No patient complications were reported.Device was returned for further 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: 19982780
• Report Number: 2124215-2024-50526
• Device Sequence Number: 2846621
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 01/05/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030795537
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 71 KG