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

Model Number G407209

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

Patient Problem Cardiac Perforation (2513)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Related manufacturing reference: 9680001-2016-00090, 2182269-2016-00028.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed and the circular mapping and ablation catheters were advanced to the left atrium.During geometry creation, fluoroscopy revealed that cardiac motion had decreased.An echocardiogram revealed a pericardial effusion, for which a pericardiocentesis was performed to stabilize the patient.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigation concluded the primary angle of the needle tip was consistent with the specification.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.The cause of the reported pericardial effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this 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: 6092102
• MDR Text Key: 59565034
• Report Number: 2182269-2016-00029
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• 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 Lot Number: 4659028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2014
• 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: REFLEXION SPIRAL CATHETER; TACTICATH ABLATION CATHETER
• Patient Outcome(s): Required Intervention