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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
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 during a procedure to treat atrial fibrillation/flutter (afib/flutter), an intellanav stablepoint catheter was selected for use.It was observed that stablepoint flush port was leaking, spraying fluid out of the proximal flushport/stopcock connector.No error message was displayed and no damage to the luer was noticed.Flow rate was set as fast flush for preparation.Catheter was then replaced and the issue was resolved.Procedure was completed successfully without any patient complications.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The intellanav stablepoint catheter was evaluated by boston scientific.Upon receipt at our post market laboratory, the device was visually inspected, and it was found that the device has the irrigation tube partially detached, consequently confirming the reported complaint tubing set leak.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation/flutter (afib/flutter), an intellanav stablepoint catheter was selected for use.It was observed that stablepoint flush port was leaking, spraying fluid out of the proximal flushport/stopcock connector.No error message was displayed and no damage to the luer was noticed.Flow rate was set as fast flush for preparation.Catheter was then replaced and the issue was resolved.Procedure was completed successfully without any 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: 21309426
• Report Number: 2124215-2025-05602
• Device Sequence Number: 8243805
• Product Code: OAE
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233(17)260308(10)33581269(21)70025509
• 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): 03/28/2025

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 Expiration Date: 03/08/2026
• Device Model Number: M004RFSDS96200
• Device Catalogue Number: M004RFSDS96200
• Device Lot Number: 0033581269
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown