MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407209

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Pericardial Effusion (3271)

Event Date 12/05/2014

Event Type  Injury  

Event Description

During an electrophysiology procedure using a brk transseptal needle, a pericardial effusion occurred.Transseptal puncture with a brk transseptal needle was attempted multiple times without success.It was difficult to visualize the fossa ovalis due to a dilated aorta.An echocardiogram revealed a pericardial effusion.The patient remained asymptomatic for approximately 40 minutes and the procedure was aborted.The pericardial effusion resolved spontaneously with no intervention.There was no performance issue with the brk transseptal needle.

Manufacturer Narrative

(b)(4).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 incident could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of the device.

• Brand Name: BRK-1? XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• 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: 4367002
• MDR Text Key: 5260347
• Report Number: 3005188751-2014-00152
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/05/2014

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: 06/30/2017
• Device Model Number: G407209
• Device Catalogue Number: G407209
• Device Lot Number: 4659031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 93