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

Model Number	NRG-E-HF-71-C1
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had experienced an angina, hypotension and pericardial effusion (pe) post procedure.During a pulse field ablation pulmonary vein isolation procedure, a nrg transseptal needle was selected for use.The procedure was completed and the patient was stable immediately post procedure.Shortly after in recovery, the patient complained of angina.The physician suspected possible coronary vasospasm and treated for that.Around five (5) hours later, the patient became hypotensive (systolic 70s), and increasing angina radiating to jaw.The physician saw the patient in short stay, performed an echo and found a small effusion.Chest drain was inserted and patient was stabilized after that.The physician initially thought it could have been during transseptal puncture.The nrg needle was used to cross mechanically instead of radio frequency application.However after evaluating the patient, the effusion was on the right side of the heart.Thus, the physician suspects during vascular access, the non-boston scientific (sl1) sheath used may have scraped the wall of the right atrium.The patient stayed in critical care unit overnight, and was discharged the next day.Physician noted that the may have used slightly more force.In the physician opinion, no contributions seemed from transseptal device.The device is not expected to be returned for analysis (disposed).
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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.

• 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; 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: 22500848
• Report Number: 2124215-2025-46855
• Device Sequence Number: 8615136
• Product Code: DXF
• UDI-Device Identifier: 00685447004530
• UDI-Public: (01)00685447004530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 07/14/2025

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-C1
• Device Catalogue Number: NRG-E-HF-71-C1
• Device Lot Number: 0035307121
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/14/2025
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male