MAUDE Adverse Event Report: ABBOTT BRK NEEDLE; TROCAR

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

Patient Problems Ventricular Fibrillation (2130); Asystole (4442)

Event Date 04/02/2021

Event Type  Injury  

Event Description

It was reported by the caller that after mapping in the right atrium obtaining cartosound contours of the left atrium.Gaining transseptal access, and mapping in the left atrium, the patient's rhythm was noted to be asystole.The ablation catheter was then advanced to the right ventricle and used to pace pacing was then paused.And the patient's rhythm converted to ventricular fibrillation a code was called and cpr was performed pacing was then continued.Pacing was eventually paused.And the patient's intrinsic sinus rhythm was noted the procedure was aborted no ablation had been performed the patient is currently stable pc-(b)(4).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
• MDR Report Key: 17524249
• MDR Text Key: 321130720
• Report Number: MW5131196
• 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: 06/02/2021

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