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

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/08/2018

Event Type  Injury  

Event Description

It was reported that during an afib procedure customer reported that they are not able to advance or retract the catheter from carto application during an rmt case.The functionality stopped working after the v6 upgrade.Additional information was received stating the customer had to interrupt the case because the patient got tamponade due to transseptal puncture.The tamponade came directly after transseptal puncture.The transseptal puncture was performed with a st.Jude medical brk transseptal needle and a st.Jude medical 8.5 french agilis nxt sheath.(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: 17527611
• MDR Text Key: 321131054
• Report Number: MW5134543
• 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: 04/11/2018

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
• Treatment: ST. JUDE AGILIS