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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Injury (2348); Pericardial Effusion (3271)

Event Date 03/19/2014

Event Type  No Answer Provided  

Event Description

Related manufacturer reference 3005188751-2014-00058.During an electrophysiology procedure, a cardiac tamponade occurred.While performing a transseptal puncture using a brk transseptal needle and a swartz braided transseptal introducer , the aorta was punctured.A transesophageal echocardiogram revealed a pericardial effusion.The patient became hypotensive and complained of chest pain.A pericardiocentesis was performed which stabilized the patient.The patient was transferred to icu in stable condition.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.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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is an inherent risk during the use of this device in the heart.

• Brand Name: TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east country road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3783527
• MDR Text Key: 4439557
• Report Number: 3005188751-2014-00059
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/19/2014

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
• Device Expiration Date: 11/30/2016
• Device Model Number: G407209
• Device Lot Number: 4383163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: SWARTZ BRAIDED TRANSSEPTAL INTRODUCER; 407439/4352404
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 75