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

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 03/04/2024

Event Type  Death  

Event Description

It was reported that while looking at the ultrasound image and assessing the anesthesia readings such as blood pressure, they noticed a pericardial effusion caused by a perforation.They confirmed the effusion with an x-ray and an echocardiogram.Transseptal puncture was performed with an abbott brk needle and sl1 sheath.No ablation was performed.Medical intervention provided was a pericardiocentesis.The caller reported that 375 ccs of fluid was removed from the patient and recycled.The patient underwent open heart surgery and died on (b)(6) 2024.The patient was female, 78 years old.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): ABBOTT / ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
• MDR Report Key: 18940441
• MDR Text Key: 338128405
• Report Number: MW5152986
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/18/2024

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: 03/19/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female