MAUDE Adverse Event Report: ABBOTT/ ST. JUDE MEDICAL, INC. BRK-1 TRANSSEPTAL NEEDLE; TROCAR

Model Number G407209

Patient Problem Cardiac Tamponade (2226)

Event Type  Injury  

Event Description

First a map of the right atrium was performed with pentaray, decanav and stsf.Then, the transeptal phase was started, puncture was performed and pentaray was introduced in the left.In that moment, the physician realized there was a tamponade.Pericardiocentesis was performed.Patient became stable and was sent to intensive care unit under supervision.Reference report: mw5144918 and mw5144919.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ABBOTT/ ST. JUDE MEDICAL, INC.
• MDR Report Key: 17611953
• MDR Text Key: 322037427
• Report Number: MW5144917
• 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: 08/22/2023

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
• Device Model Number: G407209
• Device Lot Number: 8898166
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2023
• Patient Sequence Number: 1