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	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis; however, it has not yet been evaluated.Upon completion of the failure analysis of the complaint device, if any further relevant information is identified during the review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a leak was observed at the connection between the flush port and the intellegen tubing, and the flush port at the end of the catheter was damaged.An intellanav stablepoint catheter was used to treat atrial fibrillation and flutter during an ablation procedure.During the procedure, while mapping in the right atrium (ra), a leak was observed at the connection between the flush port and the intellegen tubing.The catheter was connected to the tubing and was flushing properly before the procedure.Upon reseating the connection, the physician observed that the flush port at the end of the catheter was damaged.No ablations were performed prior to observing the issue.The catheter was replaced, and the procedure was successfully completed without patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post-market quality assurance laboratory, the returned intellanav stablepoint catheter was inspected.A fedex image was attached, but it did not contribute to the investigation.Therefore, a visual inspection was conducted, revealing that the tubing was partially detached/separated from the luer fitting at the adhesive joint.Based on all available information, the reported event of fluid leakage was confirmed, as the failure was reproducible.
Event or Problem Description
It was reported that a leak was observed at the connection between the flush port and the intellegen tubing, and the flush port at the end of the catheter was damaged.An intellanav stablepoint catheter was used to treat atrial fibrillation and flutter during an ablation procedure.During the procedure, while mapping in the right atrium (ra), a leak was observed at the connection between the flush port and the intellegen tubing.The catheter was connected to the tubing and was flushing properly before the procedure.Upon reseating the connection, the physician observed that the flush port at the end of the catheter was damaged.No ablations were performed prior to observing the issue.The catheter was replaced, and the procedure was successfully completed without patient complications.The device was 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: 22479418
• Report Number: 2124215-2025-45987
• Device Sequence Number: 7943028
• Product Code: OAE
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233(17)270412(10)36290034
• 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): 08/19/2025

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: 0036290034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2025
• 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