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

Model Number	M004RFSDS96200
Medical Device Problem Codes	Difficult to Advance (2920); Improper Flow or Infusion (2954); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
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
It was reported that there was difficulty in advancing the catheter and occlusion on the metriq pump was observed.Furthermore, the catheter was difficult to irrigate, and the distal end of the catheter was bent.A stablepoint was selected for use to treat atrial fibrillation (afib) and flutter.During the procedure, there was difficulty in advancing the catheter and occlusion on the metriq pump was observed.Furthermore, the catheter was difficult to irrigate, and the distal end of the catheter was bent.The procedure was completed with another of the same device.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this intellanav stablepoint was visually inspected, and no visual defects were noted.Functional testing showed that the catheter's functional mechanism worked properly; no abnormal resistance was felt when actuating the device.Media inspection on the photo provided was the shipping information and could not confirm the reported events of catheter difficult to advance, catheter difficult to irrigate, curve kinked.During flow testing, the device that was connected to a metriq pump and purged at a rate of 60 ml/min.All six irrigation ports flowed freely.The pump was then programmed to 30ml/min, and the device was irrigated for 5 minutes without any errors or pump messages.With all available information, the reported events could not be confirmed as the reported failures were not able to be reproduced, and the device presented with no issues.
Event or Problem Description
It was reported that there was difficulty in advancing the catheter and occlusion on the metriq pump was observed.Furthermore, the catheter was difficult to irrigate, and the distal end of the catheter was bent.A stablepoint was selected for use to treat atrial fibrillation (afib) and flutter.During the procedure, there was difficulty in advancing the catheter and occlusion on the metriq pump was observed.Furthermore, the catheter was difficult to irrigate, and the distal end of the catheter was bent.The procedure was completed with another of the same device.No patient complications were reported.The device is expected to be returned for analysis.

• Brand Name: INTELLANAV STABLEPOINT
• 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: 22511245
• Report Number: 2124215-2025-46178
• Device Sequence Number: 9246692
• Product Code: OAD
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233(17)270502(10)36432015
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/26/2025

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 Model Number: M004RFSDS96200
• Device Catalogue Number: M004RFSDS96200
• Device Lot Number: 0036432015
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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