MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number 407200

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 11/13/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation 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 pericardial effusion and subsequent death could not be conclusively determined per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related mfr reference 3005188751-2014-00144, 3005188751-2014-00145, 3005188751-2014-00146, 3005188751-2014-00147, 3005188751-2014-00148, 3005188751-2014-00149.During a pulmonary vein isolation procedure, a pericardial effusion and subsequent death occurred.A livewire ep catheter was placed in the right atrium, and a supreme quadripolar ep catheter in the his.A brk transseptal needle through a fast cath transseptal introducer was used to perform a transseptal puncture and a reflexion spiral ep catheter was advanced into the left atrium for mapping purposes.A second transseptal puncture was performed with another brk transseptal needle through a second fast cath transseptal introducer and a non-sjm ablation catheter was advanced into the left atrium.It was noted this catheter appeared outside of the geometry.After further manipulation of the catheter, the patient became hypotensive and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed but the patient¿s condition deteriorated and cpr was initiated.This was unsuccessful and the patient subsequently expired.There were no performance issues with any sjm device.

• Brand Name: BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH
• 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 1897 -405; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4310997
• MDR Text Key: 16586577
• Report Number: 3008452825-2014-00053
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 407200
• Device Lot Number: 4674822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• 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: SUPREME QUADRIPOLAR EP CATHETER; FAST CATH TRANSSEPTAL INTRODUCER X2; REFLEXION SPIRAL EP CATHETER; LIVEWIRE DUO-DECAPOLAR EP CATHETER; BIOSENSE WEBSTER ICE CATHETER; BRK TRANSSEPTAL NEEDLE; BIOSENSE WEBSTER THERMOCOOL ABLATION CATHETER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 85