MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT BRK-1 TRANSSEPTAL NEEDLE; TROCAR

Device Problems Structural Problem (2506); Compatibility Problem (2960); Material Protrusion/Extrusion (2979)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/09/2022

Event Type  Injury  

Event Description

During a pvi, a severe drop in blood pressure was detected shortly (approx.8min) after the transseptal puncture.Immediate control by tee revealed a pericardia! effusion.The pericardium was then punctured and a liter of blood was drawn during the course.The patient was subsequently transferred to the intensive care unit in stable condition.The case was thus discontinued and not finished.No ablation was performed up to this point.The operator suspected myocardial perforation during transseptal puncture.He objects to the fact that the needle (abbott, brk xs) protrudes too far from the dilator of the fixed sheath (biosense webster, cardiaguide).He suspects this to be the reason for the pericardia! perforation.Product involved: cardiaguide"' fixed curved braided transseptal sheath, ref: (b)(4), unknown lot nr, the device was not reprocessed.No further information available.Was surgery delayed due to the reported event? yes.If yes, number of minutes: unknown.Action taken when event occurred? the pericardium was then punctured and a liter of blood was drawn during the course.The patient was subsequently transferred to the intensive care unit in stable condition.Was procedure successfully completed? no.Were fragments generated? no patient status/ outcome/ consequences? yes (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ABBOTT BRK-1 TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17488375
• MDR Text Key: 320685131
• Report Number: MW5121074
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1