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

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/14/2024
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.A separate problem report will be filed for versacross rf wire and the nrg needle.
Event or Problem Description
It was reported a pericardial effusion (pe) leading to cardiac tamponade occurred.The procedure was cancelled.It was reported during a watchman left atrial appendage closure (laac) procedure, two nrg transseptal needles and a versacross connect for laac kit was selected for use.During transeptal, the physician struggled to visualize a tent on the fossa.The first attempt was with the versacross connect system but was unsuccessful.Then, the physician switched to a non-boston scientific (sl0) sheath with nrg needle but it was unsuccessful again.A third attempt was made with another non-boston scientific (agilis) sheath with a new nrg needle.At this time, an effusion was observed around the right atrium (ra) or right ventricular (rv).The physician aborted the case and proceeded to tap the patient.A dull red color 545ml total removed but 160ml given back to patient.The patient was hospitalized for the procedure and was to remain overnight for monitoring.The device is not expected to be returned for analysis (disposed).No pe was noted prior to the procedure.The patient was not under warfarin at the time.Eliquis was the patient oac and she was to be switched to plavix asa post watchman.In the physician opinion, the prominent eustachian valve gave challenges to access superior vena cava (svc), attempting to reach septum was challenging.The pe occurred sometime during the transseptal attempts.The physician could not visualize tip on the septum with all three devices.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20834407
• Report Number: 2124215-2024-76163
• Device Sequence Number: 8738710
• Product Code: DXF
• UDI-Device Identifier: 00685447004530
• UDI-Public: 00685447004530
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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: 0033571786
• 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: 11/14/2024
• Initial Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White