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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ablation procedure, an intellanav stablepoint catheter was selected for use.At the end of the case, the patient went into typical atrial flutter.The physician used a standard curve stablepoint catheter to ablate the cti.During ablation, the physician was notified by the bsc clinical specialist many times that high force was being reported on the catheter.Standard protocol was followed to warm up the stablepoint catheter and was zero'd while floating in the atrium; no errors were appearing otherwise on the catheter so the high force readings were assumed to be accurate.Physician ignored warnings from the clinical and from the opal software flashing red on the screen and continued to ablate at forces of 80+ grams throughout the case.An ultrasound clinical specialist notified the physician that she saw a pericardial effusion forming around the right atrium.Physician attempted to get better views on the ultrasound machine and diagnose this issue.He did not see an effusion and continued to ablate to finish with bi-directional block on the cti line.Overnight, the patient was diagnosed to have a pericardial effusion that required a pericardial window to drain this excess fluid.No further information regarding the patient status was able to be provided.The device is not expected to be returned as it was disposed.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because the device was discarded.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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: 21952982
• Report Number: 2124215-2025-28209
• Device Sequence Number: 9122328
• Product Code: OAE
• UDI-Device Identifier: 08714729992233
• UDI-Public: (01)08714729992233
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 05/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 04/11/2025
• Initial Report FDA Received Date: 05/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown