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); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical study interrupt af clinical study id (b)(4).It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.During ablation, the generator displayed a high temperature error.The catheter was inspected; it was found that there was fluid leaking from the proximal end of the handle and there was a break in the catheter irrigation connection.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter is expected to be returned for further analysis.
Additional Manufacturer Narrative
Intellanav mifi open-irrigated catheter was evaluated by boston scientific.Visual inspection noted the irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint.Laboratory analysis was able to confirm the reported clinical observation.
Event or Problem Description
Clinical study interrupt af clinical study id pm009, subject id: (b)(6).It was reported that during an ablation procedure to treat an atrial fibrillation (afib), an intellanav mifi open-irrigated catheter was selected for use.A maestro 4000 generator and a metriq pump were also in use.Flow rate was 17ml/min.During ablation, the generator displayed a high temperature error.The catheter was inspected; it was found that there was fluid leaking from the proximal end of the handle and there was a break in the catheter irrigation connection.Catheter was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter was returned to boston scientific for laboratory 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: 16644206
• Report Number: 2124215-2023-14126
• Device Sequence Number: 5340240
• 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): 04/27/2023

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: 01/08/2025
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030815779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG