MAUDE Adverse Event Report: ABBOTT MEDICAL BRK NEEDLE; TROCAR

Patient Problem Cardiac Tamponade (2226)

Event Date 01/23/2024

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac ablation procedure and patient experienced cardiac tamponade during transseptal puncture and required hospitalization.The most suspected device is the needle and sheath utilized for the transseptal puncture and/or the sheath (abbott sl1 sheath, st jude brk needle) utilized to cross through the septum after puncture.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report #mw5151841.

• Brand Name: BRK NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18767006
• MDR Text Key: 336282184
• Report Number: MW5151842
• 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: 02/15/2024

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: 02/22/2024
• Patient Sequence Number: 1