MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY, INC. NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-98-C1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Baylis nrg needle was not receiving the rf energy needed to be going through it to go transseptal.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY, INC.; 11320 route 9; champlain NY 12919
• MDR Report Key: 16681214
• Report Number: 16681214
• Device Sequence Number: 12560566
• Product Code: DXF
• UDI-Device Identifier: 00685447000259
• UDI-Public: (01)00685447000259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/28/2023
• Report Date (Section F): 03/28/2023

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 Model Number: NRG-E-HF-98-C1
• Device Lot Number: NGFF041122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White
• Date Report Sent to FDA: 03/28/2023