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

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Perforation (2513)

Event Date 06/09/2014

Event Type  Injury  

Event Description

During an electrophysiology procedure using a brk transseptal needle, a cardiac perforation occurred.A non-sjm catheter was advanced to the left atrium after a transseptal puncture with a brk transseptal needle and an unknown introducer.A cardiac perforation was noted via fluoroscopy and confirmed with an echocardiogram.A pericardiocentesis was performed and the patient was transferred to the operating room prior to removal of the catheter and introducer in case surgical intervention was required.Further information has been requested but is not yet available.

Event Description

During an atrial fibrillation ablation procedure using a brk transseptal needle, a cardiac perforation occurred.During transseptal puncture, the brk transseptal needle was inadvertently advanced into the aorta.The procedure was stopped and the patient was transferred to surgery to remove the needle.The needle was removed with no further intervention required and the patient recovered without issue.There were no performance issues with the needle.

Manufacturer Narrative

Additional information: 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 was procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK TRANSSEPTAL NEEDLE
• 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: 4042452
• MDR Text Key: 4860299
• Report Number: 3005188751-2014-00100
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention