MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE; TROCAR

Catalog Number 407201

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 06/28/2016

Event Type  Injury  

Event Description

This letter is to inform you of this event as the suspect device {st.Jude medical transseptal needle, model brk-1, ref.(b)(4) and st.Jude braided transseptal guiding introducer, model swartz, ref.(b)(4) ) are not manufactured or imported by biosense webster, inc.Event description: on 6/28/2016 at 17:30 pm at (b)(6) clinic sofia, bulgaria, during pvi procedure done by dr.(b)(6), following a transseptal puncture a pericardia effusion occurred, which led to the abandonment of the procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BRK-1 TRANSSEPTAL NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17534585
• MDR Text Key: 321221682
• Report Number: MW5141486
• 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: 07/15/2015

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
• Device Catalogue Number: 407201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: ST. JUDE BRAIDED TRANSSEPTAL GUIDING INTRODUCER, 4