MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC (AF-MINNETONKA) TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM

Model Number G407209

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 06/26/2014

Event Type  Injury  

Event Description

During a ventricular tachycardia ablation procedure using a brk transseptal needle, a cardiac tamponade occurred.A non-sjm decapolar ep catheter was placed in the coronary sinus.Transseptal puncture was performed using fluoroscopic guidance with a brk transseptal needle and a swartz braided transseptal introducer was then advanced into the left atrium.A few minutes later, the patient became hypotensive and convulsed.An echocardiogram revealed a large pericardial effusion which led to a cardiac tamponade.Cardiopulmonary resuscitation was initiated and a pericardiocentesis was attempted unsuccessfully due to clotting in the pericardium.A thoracotomy was performed, revealing a perforation in the aorta.The aorta was repaired and the pericardium was drained of blood, which stabilized the patient.The patient was then sent to recovery and was placed under observation.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigations are inconclusive since the device was not returned for analysis.Our analysis was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported cardiac tamponade was procedure related.Per the ifu, cardiac perforation is a known risk during use of the device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3954832
• MDR Text Key: 4557011
• Report Number: 3005188751-2014-00085
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: G407209
• Device Lot Number: 4474949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (407449/4274045); (MODEL/LOT UNK); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; SORIN XTREME DECAPOLAR EP CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 86