MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Lot Number	NGFB061123
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a nrg transseptal needle was selected for use.A perforation was reported.The procedure was cancelled.During a watchman laac procedure, while attempting the transseptal puncture, the nrg needle punctured the aortic root.The set up for transseptal was normal flow, and the physician saw a visible tent in the septum before apply energy to the nrg.After entry was applied the air/bubble artifact was apparent in the aorta, maintained position and called for surgical backup.Thus, the procedure was cancelled.The patient was hemodynamically stable, and was taken to the surgery room for repair.The device is not expected to be returned for analysis.The patient was admitted to hospital beyond standard of care and patient did good, and it has been discharged.It was further confirmed that no perforation nor pericardial effusion was noted prior to procedure.Also, there were multiple pacemaker wires to work around to get to septum.No malfunctions noted with the device.In the physician's opinion, the nrg needle has contributed to the perforation, due to its usage.
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.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19255749
• Report Number: 2124215-2024-27577
• Device Sequence Number: 17737605
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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 Lot Number: NGFB061123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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: 72 YR
• Patient Sex: Female