MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE; TROCAR

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

During the atrial fibrillation and atrial flutter ablation procedure, after transseptal procedure, the patient's blood pressure dropped and the physician noticed a pericardial effusion on the intracardiac echography.Physician monitored the effusion and blood pressure continued to drop.Therefore, the physician performed a pericardial puncture and installed a drain to remove the blood from the pericardium.With continuous live intracardiac echography, physician noted that the bleeding was active ? and could not be controlled.Physician decided to send the patient to cardiac surgery.Physician believed the complication occurred during the transseptal puncture.The patient recovered after cardiac surgery with no additional complications.It was not known if the surgery was delayed due to the reported event.It was not known if the procedure was successfully completed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17534171
• MDR Text Key: 321159293
• Report Number: MW5141074
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2019

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1