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

Lot Number 0029063537

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 02/21/2023

Event Type  Injury  

Event Description

It was reported that during a procedure using an intellanav stablepoint open-irrigated catheter the patient experienced cardiac tamponade.During mapping the patient exhibited a drop in blood pressure.An echocardiogram was performed, and they confirmed cardiac tamponade.Pericardiocentesis was performed before the patient was transferred to surgery to close a perforation in the left atrial appendage.The procedure was not completed due to the interventions required for the patient complication, and it is not clear what device caused the perforation.The patient was admitted to the hospital following the surgery and recovery is still ongoing.It is unknown if the device will be returned for analysis.

Manufacturer Narrative

Based upon analysis of all available information, investigation found no evidence to indicate that the cardiac tamponade was related to product performance of the intellanav mifi open-irrigated ablation catheter.There was no report of any device performance concerns.The complaint patient events reported are known potential adverse events related with the use of the device and are noted within the indications/instructions for use (ifu).Therefore, all compiled information on this investigation determines that the most probable cause is known inherent risk of device since the complaint patient events reported by the physician is known and documented in the labeling.

• Brand Name: INTELLANAV STABLEPOINT OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16590379
• MDR Text Key: 311755528
• Report Number: 2124215-2023-09418
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Lot Number: 0029063537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization