MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a nrg transseptal needle was selected for use.During the procedure, it was mentioned that it was not possible to cross the septum.A first nrg needle was advanced into the right atrium (ra) through a non-boston scientific sr0 sheath, several applications of energy were delivered without transeptal access.Hence, a second nrg needle was then opened and advanced through the sr0.The second needle was placed on the septum and several attempts were made to deliver energy without success.Restarting the bmc rf generator and replacing the grounding pad and cable were also tried and no improvement.Eventually a trickle of saline was noticed in the left atrium was noted on intra cardiac echo.The nrg needle was then removed, and a wire was inserted and crossed the septum.The sr0 was advanced over the wire and the procedure was completed.No patient complication was reported.The device is not expected to be returned for analysis (disposed).No other issues were reported.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.A separate problem report will be filed for the first nrg needle.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21599243
• Report Number: 2124215-2025-15763
• Device Sequence Number: 8938849
• Product Code: DXF
• UDI-Device Identifier: 00685447004530
• UDI-Public: 00685447004530
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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-71-C1
• Device Catalogue Number: NRG-E-HF-71-C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female