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

Device Problem Poor Quality Image (1408)

Patient Problem Cardiac Perforation (2513)

Event Date 03/10/2014

Event Type  Injury  

Event Description

During an atrial fibrillation procedure when performing transseptal puncture with a sjm brk needle, the right coronary cusp was punctured.The pt was stable and no intervention was required.The procedure was then cancelled.The physician believed the event was due to poor imaging issues with a non-sjm ice catheter.

• Brand Name: TRANSSEPTAL NEEDLE
• Type of Device: BRK SERIES
• Manufacturer (Section D): ST. JUDE MEDICAL, INC (AF-MINNETONKA); minnetonka MN 0000
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane n; plymouth, MN 55442-0000 ; 6517565400
• MDR Report Key: 3850456
• MDR Text Key: 4406717
• Report Number: 3005188751-2014-00074
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• 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: 04/22/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/16/2014
• 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