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

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that pericardial effusion (pe) occurred.During a pulmonary vein isolation for paroxysmal atrial fibrillation procedure, a nrg transseptal needle was selected for use.The procedure was guided by using transesophageal echocardiogram (tee) and fluoroscopy.The transeptal puncture completed.It was challenging to engage the fossa ovalis (fo) initially using tee and fluoro guidance.A contrast was done staining pericardium/septum.Device were pulled back and reengaged fo.A second transseptal attempt was successful with nrg.Post ablation (total applications 43) noted small to moderate effusion on tee without right ventricular (rv)/ right atrium collapse.Patient was hemodynamically stable.Patient was discharged the same day following a post procedure transthoracic echo.The device is not expected to be returned for analysis (disposed).The same nrg was used for both tsp.Despite the use of tee, the heart axis was slightly off making visualization of the fossa difficult.The fossa was difficult to engage when the needle dropped down.Additional heparin bolus only given once no acute effusion was noted on tee following the tsp.Dye staining on the septal myocardium noted after the tsp.Spontaneous resolution without any treatment.No malfunction or contributions from nrg noted.

• 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: 22012269
• Report Number: 2124215-2025-30671
• Device Sequence Number: 5228266
• 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): 05/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NRG-E-HF-71-C1
• Device Catalogue Number: NRG-E-HF-71-C1
• Device Lot Number: 0035944704
• 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: 04/23/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 02/12/2025
• 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
• Patient Sex: Unknown