MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problem Cardiac Perforation (2513)

Event Date 12/21/2018

Event Type  Injury  

Event Description

Related manufacturer reference: 9680001-2019-00004, 3005334138-2019-00018.During a ventricular tachycardia ablation procedure, a pericardial effusion occurred.A brk needle was used for transseptal puncture to map the vt in the left ventricle.Mapping was performed with the advisor hd and the tacticath se was in the left ventricle.The patient went into vt and was cardioverted multiple times.During ablation of the ischemic vt in the left ventricle with the tacticath se, the patient went into vt and became hypotensive.The patient was cardioverted to sinus rhythm, however remained hypotensive.An echocardiogram confirmed a pericardial effusion for which a pericardiocentesis was performed to stabilize the patient.It is unknown at what moment the effusion occurred.There were no performance issues with any abbott device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number is unavailable.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8234025
• MDR Text Key: 132629613
• Report Number: 3008452825-2019-00012
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SE; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE; ADVISOR¿ HD GRID MAPPING CATHETER, SE; TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Patient Outcome(s): Required Intervention