MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-71-C0
Medical Device Problem Codes	Failure to Deliver Energy (1211); Off-Label Use (1494); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that nrg transseptal needle selected for use.During procedure, when the nrg needle was connected to the electrical console, a generic error message appeared on the screen of the bmc rf generator.After pressing 'dismiss,' the display indicated that the product was 'ready' for use.After three attempts to activate the radiofrequency with the same needle, the transseptal puncture was not performed.The radio frequency was delivered the three times, the sound for it was heard, but the septum was not crossed.No error occurred when the rf energy was activated.An error only appeared when the first needle was connected, the cable was not replaced.The septum was quite floppy.Generator was in ready mode when the issue was encountered.No challenges noted related to the patient anatomy.There was tenting of the septum confirmed before attempting to deliver rf energy.The first needle was manually reshaped prior to the procedure.Hence, the device was replaced and the procedure proceeded normally.Procedure was completed.No patient complication was reported.The device is not expected to return for analysis as disposed.
Event or Problem Description
It was reported that nrg transseptal needle selected for use.During procedure, when the nrg needle was connected to the electrical console, a generic error message appeared on the screen of the bmc rf generator.After pressing 'dismiss,' the display indicated that the product was 'ready' for use.After three attempts to activate the radiofrequency with the same needle, the transseptal puncture was not performed.The radio frequency was delivered the three times, the sound for it was heard, but the septum was not crossed.No error occurred when the rf energy was activated.An error only appeared when the first needle was connected, the cable was not replaced.The septum was quite floppy.Generator was in ready mode when the issue was encountered.No challenges noted related to the patient anatomy.There was tenting of the septum confirmed before attempting to deliver rf energy.The first needle was manually reshaped prior to the procedure.Hence, the device was replaced and the procedure proceeded normally.Procedure was completed.No patient complication was reported.The device is not expected to return for analysis as disposed.
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) initial reporter facility name (e1), in section e, initial reporter.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23638650
• Report Number: 2124215-2025-86172
• Device Sequence Number: 9978523
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: (01)00685447000204(17)270917(10)34916726
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• Device Lot Number: 0034916726
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/28/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 09/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female