MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. BRK TRANSSEPTAL NEEDLE; TROCAR

Patient Problems Needle Stick/Puncture (2462); Pericardial Effusion (3271)

Event Date 02/13/2024

Event Type  Injury  

Event Description

A pericardial effusion after transseptal puncture.There was a drop in blood pressure, and pericardiocentesis was performed.The devices used for transseptal were brk needle, and agilis small (non biosense webster products).The pericardial effusion occurred prior to use of ablation catheter and no ablation was performed.Reference report: mw5152332.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, CARDIOLOGY DIVISION, INC.
• MDR Report Key: 18845434
• MDR Text Key: 337122325
• Report Number: MW5152331
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Patient Sequence Number: 1
• Treatment: AGILIS STEERABLE CATHETER INTRODUCER