MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. TRANSSEPTAL NEEDLE, BRK SERIES

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Related manufacturer reference 3005188751-2015-00039.According to a japanese literature article, a cardiac perforation occurred.During an atrial tachycardia electrophysiology (ep) procedure, a brk needle and a swartz introducer were used for transseptal puncture.Difficulty confirming left atrial placement was experienced due to the presence of a previous xenomedica patch.The brk needle and swartz introducer advanced over the puncture position and reached to the ascending aorta.An echocardiogram was negative for a pericardial effusion.An aortogram confirmed transverse shunt blood flow via fontan root around from the left coronary cusp.The patient was stable and the ep procedure was abandoned for patient monitoring.Following the procedure, a transverse blood flow shunt between the aorta and fontan route was confirmed and the patient was treated with embolization with coils.

Manufacturer Narrative

(b)(4).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 as the model and lot numbers of the device were unavailable.Based on the information received, the cause of the reported cardiac perforation could not be conclusively determined and may be procedure related.Per the ifu, cardiac perforation in a known risk with this device.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• 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: 4720814
• MDR Text Key: 5584861
• Report Number: 3005188751-2015-00040
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR