MAUDE Adverse Event Report: ABBOTT MEDICAL BRK NEEDLE; TROCAR

Patient Problems Bradycardia (1751); Chest Pain (1776); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 07/04/2023

Event Type  Injury  

Event Description

Operator reported that when accessing left atrium via transeptal puncture (non bwi (biosense webster, inc.) kit), across a very stiff septum (several previous left atrial procedures), the pericardial effusion was caused as a result.Hypotension, bradycardia and chest pain occurred 5-10 minutes post transeptal puncture.No ventricular arrhythmias.Echocardiogram to confirm effusion and pericardiocentesis performed very quickly and 1,100ml of blood was drained from pericardial space.No anesthetic or cardiac support required.Case abandoned, no ablations performed, no further mapping performed post drain insertion.No bwi product issues.Reference report: mw5144732.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17573154
• MDR Text Key: 321553603
• Report Number: MW5144731
• 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: Other
• Type of Report: Initial
• Report Date: 08/16/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2023
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH.