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

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that a 68-year-old male patient with cardiomegaly and pulmonary hypertension history, underwent an atrial fibrillation (afib) ablation procedure with a navistar rmt thermocool catheter and suffered cardiac tamponade requiring pericardiocentesis, blood transfusion and surgical intervention.Additional information was received on 10/21/2018: 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 transseptal needle, st.Jude sl1 sheath and safe sept wire.The suspected device is the st.Jude medical brk transseptal needle.(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: 17534021
• MDR Text Key: 321046238
• Report Number: MW5140924
• 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: 11/15/2018

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
• Patient Age: 68 YR