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 Codes	Fluid/Blood Leak (1250); Improper Flow or Infusion (2954); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was unable to flush properly and the flush port on the ablation catheter was broken.During an ablation procedure to treat paroxysmal atrial fibrillation and atrioventricular nodal reentry tachycardia (avnrt), an intellanav mifi open-irrigated was selected for use.The catheter was connected to the catheter connection cable and metriq tubing; however, it was observed that it was unable to flush properly.It was noted that the flush port on the ablation catheter was broken.Another of the same device was used and the procedure was completed.There were no patient complications as a result of this event.The device is expected to 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 device has not been received for analysis.However, a media inspection was performed there was a picture attached to the complaint, and it is possible to confirm that the tubing set fluid leak, tubing set damaged/defective.The irrigation extension tubing was found partially detached/separated from the luer fitting at the adhesive joint.With all the available information, boston scientific was able to confirm the reported clinical observation of the catheter was unable to flush properly and the flush port on the ablation catheter was broken.
Event or Problem Description
It was reported that the catheter was unable to flush properly and the flush port on the ablation catheter was broken.During an ablation procedure to treat paroxysmal atrial fibrillation and atrioventricular nodal reentry tachycardia (avnrt), an intellanav mifi open-irrigated was selected for use.The catheter was connected to the catheter connection cable and metriq tubing; however, it was observed that it was unable to flush properly.It was noted that the flush port on the ablation catheter was broken.Another of the same device was used and the procedure was completed.There were no patient complications as a result of this event.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that the catheter was unable to flush properly and the flush port on the ablation catheter was broken.During an ablation procedure to treat paroxysmal atrial fibrillation and atrioventricular nodal reentry tachycardia (avnrt), an intellanav mifi open-irrigated was selected for use.The catheter was connected to the catheter connection cable and metriq tubing; however, it was observed that it was unable to flush properly.It was noted that the flush port on the ablation catheter was broken.Another of the same device was used and the procedure was completed.There were no patient complications as a result of this event.The device was returned for analysis.
Additional Manufacturer Narrative
Block d4 (unique identifier) has been corrected and block h11 (device analysis) has been updated with investigation re-closed on may 27, 2025.Upon receipt at our post market quality assurance laboratory, this intellanav mifi open-irrigated was visually inspected and the tubing was found partially detached from the luer fitting at the adhesive joint, confirming the reported events of tubing set fluid leak and tubing set damaged/defective.The reported events were traced to the design specification.

• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21836773
• Report Number: 2124215-2025-23019
• Device Sequence Number: 20993168
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: (01)08714729938361(17)260820(10)34673563
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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: 08/20/2026
• Device Model Number: M004PMR96200
• Device Catalogue Number: M004PMR96200
• Device Lot Number: 0034673563
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 05/27/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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 Sex: Unknown