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	Restricted Flow rate (1248); Nonstandard Device (1420); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.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.
Event or Problem Description
It was reported that the side port was bent, causing the fluid not properly flowing through the catheter.During an ablation procedure to treat atrial fibrillation, an intellanav stablepoint catheter was selected for use.While connecting the flush to the catheter, a bend in the flush port was observed, causing the fluid not properly flowing through the catheter.The catheter was replaced and the procedure was completed successfully with no patient complications.The device was retained by the customer and will not be returned for analysis.
Event or Problem Description
It was reported that the side port was bent, causing the fluid not properly flowing through the catheter.During an ablation procedure to treat atrial fibrillation, an intellanav stablepoint catheter was selected for use.While connecting the flush to the catheter, a bend in the flush port was observed, causing the fluid not properly flowing through the catheter.The catheter was replaced and the procedure was completed successfully with no patient complications.The device was retained by the customer and will not be returned for analysis.**additional information received on february 04, 2026** no error messages were displayed, as the issue occurred before the catheter entered the patient's body during the initial flushing process.The flush rate was 60 ml per minute and was stopped immediately once the problem was identified.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on february 04, 2026 block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.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.

• 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: 24211309
• Report Number: 2124215-2026-05300
• Device Sequence Number: 5458499
• Product Code: OAD
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/27/2026

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: M004RFSDS96200
• Device Catalogue Number: M004RFSDS96200
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/27/2026
• 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