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

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/08/2018

Event Type  Injury  

Event Description

It was reported that a patient underwent an ablation procedure and suffered cardiac tamponade requiring pericardiocentesis.Additional information was received on (b)(6) 2018: the physician's opinion regarding the cause of the adverse event is that it was procedure-related and that the adverse event was caused by the transseptal needle.Transseptal puncture was performed with a st.Jude medical brk-1 transseptal needle.Pc-(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17524086
• MDR Text Key: 321132933
• Report Number: MW5131033
• 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: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1