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

Model Number 407200

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

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Date 08/08/2014

Event Type  Death  

Event Description

During a left side atrial tachycardia ablation procedure using a brk transseptal needle, the patient expired.Transseptal puncture was performed with a brk transseptal needle and it was noted the needle perforated the aorta.The patient became hemodynamically unstable and cpr was performed.Extracorporeal membrane oxygenation (ecmo) was initiated and the patient was transferred to surgery for repair of the perforation.This was unsuccessful and the patient expired.There were no performance issues with the brk transseptal needle.

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 cardiac perforation and subsequent death was procedure related.Per the ifu, cardiac perforation is a known risk during the use of the device.

• Brand Name: BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4063696
• MDR Text Key: 4900061
• Report Number: 3005188751-2014-00103
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK072278
• 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: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• 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
• Patient Outcome(s): Death