MAUDE Adverse Event Report: ST. JUDE BRK-1; TROCAR

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Perforation (2513)

Event Date 01/27/2014

Event Type  Injury  

Event Description

It was reported that there was a patient perforation during the case.A pericardio drain was performed and the patient was stabilized.Per the additional information received, the issue occurred during transseptal puncture which was prior to catheter insertion.The transseptal puncture was performed with a st.Jude brk-1 needle.Pl1-jfb5vx.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK-1
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 17534346
• MDR Text Key: 321162604
• Report Number: MW5141248
• 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: 02/18/2014

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