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

Model Number NRG-71-C0

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the device history record confirmed this lot met manufacturing requirements prior to shipment.

Event Description

The nrg transseptal needle was used for transseptal puncture in a procedure.During use of the first rf needle, the physician encountered difficulty injecting contrast to confirm positioning in the left atrium.The rf needle was removed and contrast was confirmed to be coming out of only one sideport.The rf needle was exchanged for a new device.Successful transseptal puncture was achieved using the new rf needle.When the rf needle was removed from the patient, the insulation was observed to be pushed back following use with the ancillary devices.As a result, the physician spent some time examining the device issue.The combined device issues resulted in a procedural delay of approximately 20 minutes.There was no patient injury or complication related to these issues.However, this report is being submitted due to the resulting procedural delay.Separate mdr reports have been submitted for each device used in the procedure.The report for the second device has been submitted under mfr report #: 9710452-2016-00009.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Type of Device: RF TRANSSEPTAL NEEDLE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2645 matheson blvd. east; mississauga, ontario L4W 5 S4; CA L4W 5S4
• Manufacturer Contact: meghal khakhar ; 2645 matheson blvd. east; mississauga, ontario L4W 5-S4 ; CA L4W 5S4 ; 90560
• MDR Report Key: 5620675
• MDR Text Key: 44133660
• Report Number: 9710452-2016-00008
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: NRG-71-C0
• Device Catalogue Number: NRG-71-C0
• Device Lot Number: NGFC120116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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