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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Vascular Dissection (3160)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A left atrial appendage (laa) closure procedure was being performed.A transseptal puncture (tsp) was being performed using an nrg (rf) needle.Transseptal position was aimed in the inferior/posterior and tenting to the posterior/mid was confirmed.When the rf needle was inserted, it slipped upward, and the position shifted (deviating in the direction of superior outside fossa and it is possible that an unintended location was mechanically punctured).Adjustment was performed again downward, and energization was performed in the mid position, but the needle did not come off (got stuck due to the patient anatomy), so energization was performed again.A watchman fxd curve access system (was) was advanced and it was deployed and recaptured twice.Thus, the watchan was removed so that a new transseptal with the same nrg rf needle could be performed.Upon removal of the devices, a dissection was observed.It was confirmed that there was a puncture hole in the atrial septum secundum, and the dissection of the septum extended from the puncture hole in the atrial septum secundum in a cephalic and dorsal direction.There was no accumulation of pericardial effusion.The procedure was cancelled.The physician believes the dissection occurred from the rf needle.No intervention was needed.The patient's is in good condition.The device is not expected to be returned for analysis.
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: 17162533
• Report Number: 2124215-2023-30068
• Device Sequence Number: 17578869
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: 00685447000204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/20/2023

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 Expiration Date: 10/06/2024
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFD300921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 80 YR
• Patient Sex: Unknown