MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OI

Model Number	M004RFSDS96200
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat a supra ventricular tachycardia, an intellanav open irrigated catheter was selected for use.The catheter was no flushing correctly when doing an inpatient ablation.There was no interruption of irrigation from the pump.The flow rate was set at fast flush at the beginning.Tried reconnecting the flush and flushing multiple times but the issue persisted.Finally, catheter was replaced and the issue was resolved.No patient complications were reported.The device will 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
Upon receipt at boston scientific post market laboratory the returned intellanav oi catheter was visually inspected no abnormalities were observed.Functional testing showed the catheter functional mechanism worked properly no resistance was felt.The device was connected to a known good metriq pump and was purged all six irrigation ports flow freely.The pump was programmed and the device was irrigated for 5 minutes without any errors or pump messages.The device passed all tests performed and exhibited normal device characteristics.With all available information the complaint could not be confirmed as the reported failure was not able to be reproduced and the device presented with no issues.
Event or Problem Description
It was reported that during an ablation procedure to treat a supra ventricular tachycardia, an intellanav open irrigated catheter was selected for use.The catheter was not flushing correctly when doing an inpatient ablation.There was no interruption of irrigation from the pump.The flow rate was set at fast flush at the beginning.Tried reconnecting the flush and flushing multiple times but the issue persisted.Finally, catheter was replaced and the issue was resolved.No patient complications were reported.The device will be returned for analysis.

• Brand Name: INTELLANAV OI
• Common Device Name: INTELLANAV OI
• 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: 21256502
• Report Number: 2124215-2025-03900
• Device Sequence Number: 9117201
• Product Code: OAE
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233(17)260422(10)33875818
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 04/02/2025

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: 04/22/2026
• Device Model Number: M004RFSDS96200
• Device Catalogue Number: M004RFSDS96200
• Device Lot Number: 0033875818
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown