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

Model Number	M004RFSDS9620K20
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The intellanav stablepoint catheter was not returned for analysis; however, a video was attached to the complaint.Media analysis of the video was able to confirm that some flush ports occluded.The reported clinical observations were confirmed.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that the catheter could not be sufficiently irrigated.During preparation for a procedure to treat atrial fibrillation an intellanav stablepoint catheter was selected for use.Prior to insertion some flush ports were occluded when attempting the fast flush; two or three were actually spraying and the catheter could not be properly flushed.The catheter was replaced and the procedure was completed.No patient complications were reported.The device is not expected to be returned for analysis due to disposal.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that the catheter could not be sufficiently irrigated.During preparation for a procedure to treat atrial fibrillation an intellanav stablepoint catheter was selected for use.Prior to insertion some flush ports were occluded when attempting the fast flush; two or three were actually spraying and the catheter could not be properly flushed.The catheter was replaced and the procedure was completed.No patient complications were reported.The device is not expected to be returned for analysis due to disposal.

• Brand Name: INTELLANAV STABLEPOINT?
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23840300
• Report Number: 2124215-2025-91764
• Device Sequence Number: 9599581
• Product Code: OAE
• UDI-Device Identifier: 08714729992240
• UDI-Public: (01)08714729992240
• 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): 01/29/2026

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: M004RFSDS9620K20
• Device Catalogue Number: M004RFSDS9620K20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown