MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED(OI) CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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

Event Type  Injury  

Event Description

Following an atrial flutter procedure, there was a cardiac tamponade that required pericardiocentesis.There were no complications noted during the procedure but post-procedure the patient became hypotensive in the recovery room.Once the pericardiocentesis was completed the patient was admitted.The physician does not believe that the tamponade was due to the stable point catheter, however, the cause of the tamponade was not able to be determined.Non-abbott (boston scientific) intellanav stable point open-irrigated catheter.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED(OI) CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17712742
• MDR Text Key: 323146817
• Report Number: MW5145390
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1