MAUDE Adverse Event Report: Baylis Medicale Cie Inc NRG Transseptal Needle; Catheter, Septostomy

Model Number	NRG-HF-98-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced st segment elevation and hypotension during a procedure.They received oxygen, vasopressors, and pacing resolving the issue and allowing the procedure to be completed without further complications.A farapulse procedure to treat paroxysmal atrial fibrillation was performed.An nrg transseptal needle was selected for use.After the transseptal access was achieved with the needle, a non-boston scientific sheath was advanced into the left atrium of the patient.At this time, st segment elevation was observed on inferior leads ii, iii, and avf.Hypotension was also noted.No air was observed in a device or the patient.The patient, under anesthesia, was treated with oxygen, vasopressors, and pacing to increase heart rate.The physician also evaluated the heart using intracardiac echocardiography (ice).No effusion or wall motion abnormalities were observed.After a few minutes, the patient condition resolved.The procedure was completed as expected with no further complications and is in stable condition.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• 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): Boston Scientific Corporation; cartago, 03 ; CA
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50127706
• Report Number: 2124215-2026-41633
• Device Sequence Number: 5597902
• Product Code: DXF
• UDI-Device Identifier: 00685447004448
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NRG-HF-98-C1
• Device Catalogue Number: NRG-HF-98-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: 07/16/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female