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

Model Number 407200

Device Problem Insufficient Information (3190)

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

Event Date 11/13/2014

Event Type  Death  

Event Description

Related manufacturer reference 3008452825-2014-00053, 3005188751-2014-00144, 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, a blood transfusion was administered, and cpr was initiated, which was unsuccessful.The patient¿s condition deteriorated and they subsequently expired.There were no performance issues with any sjm 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 was unavailable.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.

• Brand Name: BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4311297
• MDR Text Key: 5252743
• Report Number: 3005188751-2014-00145
• 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 Model Number: 407200
• 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
• 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: BIOSENSE WEBSTER THERMOCOOL ABLATION CATHETER; BRK TRANSSEPTAL NEEDLE; SUPREME QUADRIPOLAR EP CATHETER; REFLEXION SPIRAL EP CATHETER; BIOSENSE WEBSTER ICE CATHETER; LIVEWIRE DUO-DECAPOLAR EP CATHETER; FAST CATH TRANSSEPTAL INTRODUCER X2
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 85