MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	M004PMR9620N40
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on september 24, 2025.It was reported that noise signal interference occurred intermittently.An intellanav mifi open-irrigated catheter was used for radiofrequency ablation of supraventricular tachycardia procedure in the atrioventricular node.During the procedure, a noise signal interference occurred intermittently, and it affected potential judgment.The device was replaced and completed with another of the same device.There was no patient complications noted as a result of this event, and the patient condition following procedure was stable.However, returned device analysis revealed an obstruction on the distal end was noted.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this intellanav mifi open-irrigated catheter was visually inspected and showed no defects.Functional test showed that the functional mechanism worked properly; no abnormal resistance was felt when actuating the device.During the leak testing, the device failed the test.All six irrigation ports flow freely during flow testing; but the device was obstructed, and could not be irrigated.A continuity test was performed, and the device passed the specification test.Electrical testing, including catheter recognition and noise assessment, could not be performed due to the device's electrical condition and an obstruction at the distal end that affects flow across the device.Dissection inspection showed procedural waste found on the distal end (salt buildup, blood/tissue).The reported issue of noisy electrogram was not confirmed, however, an obstruction on the distal end was noted.Due to the physical condition of the device, the electrical test could not be performed and the reported issue cannot be established.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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: 23358833
• Report Number: 2124215-2025-75321
• Device Sequence Number: 18442149
• Product Code: OAD
• UDI-Device Identifier: 08714729938385
• UDI-Public: (01)08714729938385(17)260729(10)34527500
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 07/29/2026
• Device Model Number: M004PMR9620N40
• Device Catalogue Number: M004PMR9620N40
• Device Lot Number: 0034527500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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 Age: 21 YR
• Patient Sex: Male
• Patient Weight: 65 KG