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

Model Number	M004RFSDS96200
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after one successful lesion, a "p02 - occlusion detected" error appeared on the metriq pump when attempting to resume ablation.The physician decided to cancel the procedure due to its duration.During an atypical flutter ablation procedure to treat atrial flutter, an intellanav stablepoint catheter was used.After one successful lesion, a "p02 - occlusion detected" error appeared on the metriq pump when attempting to resume ablation.Subsequently, the catheter was removed from the body and purged, with no occlusion noted, and standby flow resumed.The catheter was then reinserted, but the same error occurred when ablation was attempted again.The physician decided to cancel the procedure due to its duration.There were no patient complications reported 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.
Event or Problem Description
It was reported that after one successful lesion, a "p02 - occlusion detected" error appeared on the metriq pump when attempting to resume ablation.The physician decided to cancel the procedure due to its duration.During an atypical flutter ablation procedure to treat atrial flutter, an intellanav stablepoint catheter was used.After one successful lesion, a "p02 - occlusion detected" error appeared on the metriq pump when attempting to resume ablation.Subsequently, the catheter was removed from the body and purged, with no occlusion noted, and standby flow resumed.The catheter was then reinserted, but the same error occurred when ablation was attempted again.The physician decided to cancel the procedure due to its duration.There were no patient complications reported as a result of this event.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this intellanav stablepoint catheter was visually inspected, and no visual damage was observed.Functional testing revealed that the catheter's functional mechanism worked properly; no abnormal resistance was felt when the device was actuated.During flow testing, the device was connected to a metriq pump and was purged at 60 ml/min.All six irrigation ports flow freely.The pump was programmed to 30ml/min, and the device was irrigated for 5 minutes without any errors or pump messages.With all available information, the reported complaint of "message- occlusion detected" could not be confirmed as the reported failure was not able to be reproduced, and the device presented with no issues.

• 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: 22102108
• Report Number: 2124215-2025-32015
• Device Sequence Number: 7122631
• Product Code: OAE
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233(17)270301(10)35968658
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/08/2025

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: 0035968658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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