MAUDE Adverse Event Report: BAYLIS MEDICAL CO., INC. NRG TRANSSEPTAL NEEDLE; RF TRANSSEPTAL NEEDLE

Model Number NRG-E-HF-71-C0

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 01/29/2014

Event Type  Injury  

Event Description

A report was received indicating that cardiac tamponade occurred in pt undergoing a cardiac ablation procedure.This report is being submitted by baylis medical as the nrg transseptal needle was one of the devices used during the procedure.During the procedure, the nrg transseptal needle was used with an sl0 introducer.The slo introducer was not supplied by baylis medical.Prior to rf energy delivery, while the physician was manipulating the devices to try to locate the desired puncture site, the assembly of transseptal devices inadvertently crossed at an unexpected site.No rf energy was applied.The physician confirmed the position of the devices in the left atrium by contrast dye injection, and continued to advance the sheath.At this point, the pt's blood pressure was observed to decrease.Pericardial effusion was then confirmed by echocardiogram.The physician indicated that a cardiac tamponade had occurred and pericardiocentesis was performed.The effusion site could not be identified.The pt prognosis was reported to be well after surgery.There is no evidence to suggest that the nrg needle caused or contributed to the unexpected perforation in the pt, which resulted in the cardiac tamponade.However, as nrg transseptal needle was one of various transseptal devices used in the procedure, baylis medical has decided to submit this report.

Manufacturer Narrative

The device was not returned to the mfr for investigation.Perforation is an inherent risk to this type of procedure.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Type of Device: RF TRANSSEPTAL NEEDLE
• Manufacturer (Section D): BAYLIS MEDICAL CO., INC.; 5959 trans-canada highway; montreal, quebec H4T 1A1; CA H4T 1A1
• Manufacturer Contact: meghal khakhar ; 2645 matheson blvd. e; mississauga, ontario L4W 5-S4 ; CA L4W 5S4 ; 6024875
• MDR Report Key: 3708511
• MDR Text Key: 16011087
• Report Number: 9710452-2014-00003
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: NRG-E-HF-71-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• Device Lot Number: NGFD090913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Patient Outcome(s): Other