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	Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
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
During procedure to treat atrial fibrillation (a fib), an intellanav mifi open-irrigated catheter was selected for use.It was reported that during ablation, the generator displayed a high temperature error.The catheter was inspected and a defect in the irrigation port was found.Fluid leaked from the catheter's handle.Catheter was replaced with another of same device and procedure was completed successfully.No patient complications were reported.Product is expected to be returned.
Event or Problem Description
During procedure to treat atrial fibrillation (a fib), an intellanav mifi open-irrigated catheter was selected for use.It was reported that during ablation, the generator displayed a high temperature error.The catheter was inspected and a defect in the irrigation port was found.Fluid leaked from the catheter's handle.Catheter was replaced with another of same device and procedure was completed successfully.No patient complications were reported.Product has been returned and analysis has been performed.
Additional Manufacturer Narrative
An intellanav mifi open-irrigated catheter was returned and analyzed.Product analysis observed the irrigation extension tubing was found partially detached-separated from the luer fitting at the adhesive joint.Therefore, the reported complaint catheter "handle leak" and generator "message - d07 temperature too high" are confirmed.The pictures provided by the costumer and the returned device intellanav mifi open-irrigated catheter was analyzed and confirmed that the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint, therefore, the reported complaint is confirmed.

• 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: 16590764
• Report Number: 2124215-2023-09261
• Device Sequence Number: 16899347
• 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): 04/25/2023

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: 11/16/2024
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030557241
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown