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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced hypotension.The procedure was cancelled.During a pulse field ablation procedure, a nrg transseptal needle was selected for use.The physician performed transseptal puncture (tsp).Shortly after the tsp and prior to insertion of the faradrive, there was a sudden drop in the blood pressure.The physician did not see an effusion, and noted normal left atrium pressures after crossing.The case was aborted due to a sudden drop in the patient's blood pressure and the patient was sent for a chest computed tomography (ct) scan.The patient was discharged on (b)(6) 2025.The device is not expected to be returned for analysis (disposed).Ct initially showed consolidation of the left lung.Hypotension was treated with calcium, adrenaline, phenylephrine, vasopressin, sodium bicarbonate.The patient has had a previous attempt at ablation and had the same response following transseptal.The physician believes this is related to the procedure, but not to the nrg needle product.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the complete 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): 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: 21977565
• Report Number: 2124215-2025-29311
• Device Sequence Number: 9274145
• Product Code: DXF
• UDI-Device Identifier: 00685447004523
• UDI-Public: (01)00685447004523
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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-E-HF-71-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• 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: 04/17/2025
• Initial Report FDA Received Date: 05/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown