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	Leak/Splash (1354); Detachment of Device or Device Component (2907); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intellanav mifi open-irrigated catheter was returned and analyzed.Visual inspection confirmed that the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint.Therefore, the reported complaint of tubing set "detachment of device or device component, cath-poor temperature control - higher than expected and leak" was confirmed.This device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event and there was no evidence that the device was used in a manner inconsistent with the labelled indication."cause traced to device design" was assigned to this complaint since the problem found was traced to the design specification.
Event or Problem Description
During procedure to treat atrial flutter, an intellanav mifi open-irrigated catheter was selected for use.It was reported that during ablation the generator alarmed "excessive temperature" and it was noted that the luer lock connection was fractured on the catheter and also leaking fluid.Catheter was replaced with another of different model and case proceeded and completed successfully.No patient complications reported.Product has been returned and analysis has been performed.

• 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: 16573449
• Report Number: 2124215-2023-08509
• Device Sequence Number: 7150199
• 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
• Report Date (Section B): 03/20/2023

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: 11/09/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030519181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown