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

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

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 01/06/2021

Event Type  Injury  

Event Description

It was reported that the patient suffered a pericardial effusion due to a perforation on the posterior wall of the left atrium.The physician noticed the location of the needle on fluoroscopy and when trying to "pull back" there was no fluid.The perforation was confirmed with a biosense webster, inc.Soundstar? eco diagnostic ultrasound catheter and transesophageal echo (tee) was also performed.A pericardiocentesis was performed and the fluid that was being removed was being returned to the patient.The caller does not know how much fluid that was.The caller confirmed the patient was hemodynamically stable throughout the entire procedure.The procedure was abandoned at the time and the patient was transferred to a floor bed for recovery and observation.The event occurred during the transeptal puncture that was performed using a brk transseptal needle from st.Jude medical.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17525059
• MDR Text Key: 321138966
• Report Number: MW5132001
• 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: 02/02/2021

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