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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history record for the lot in question confirmed that all parts met manufacturing requirements prior to release.There was no patient impact or consequence.Baylis medical company inc.Has decided to report this event due to the procedural delay that occurred.
Event or Problem Description
During an atrial fibrillation procedure, the physician used a nrg transseptal needle to perform the transseptal but at the moment of applying radiofrequency (rf), the generator showed a message (unknown code) and didn't apply rf.There were seven attempts but the rf didn't occur.A new nrg needle was opened and it worked successfully.Baylis medical company inc.Has decided to report this event due to the procedural delay of 20 minutes that occurred for this procedure.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: RF TRANSSEPTAL NEEDLE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• MDR Report Key: 9154270
• Report Number: 9710452-2019-00023
• Device Sequence Number: 14094113
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: (01)00685447000204(17)211128(10)NGFE141218
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFE141218
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other