MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC TRANSSEPTAL NEEDLE; TROCAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 04/06/2022

Event Type  Injury  

Event Description

During an atrial flutter ablation procedure, a pericardia! effusion occurred.The patient became hypotensive and an ultrasound revealed a pericardia! effusion on left side of the heart.The procedure was stopped and a pericardiocentesis was performed which stabilized the patient.There were no performance issues with the abbott devices.The physician stated the cause of the perforation may have been due to a difficult transseptal puncture as the septum was thick.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MEDTRONIC TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17533940
• MDR Text Key: 321149591
• Report Number: MW5140843
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1