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

Model Number	NRG-E-HF-98-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	03/28/2023
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.
Event or Problem Description
It was reported that during a left atrial appendage (laa) closure procedure, a nrg needle was selected for use.Post transeptal puncture it was difficult to get a non-boston scientific sheath across the septum.Once the sheath was across, the staff prepped the watchman access sheath for exchange and during this time, left sided access was lost and transesophageal echocardiography (tee) imaging noticed a new pericardial effusion.The patient vitals started to decline, the procedure was cancelled and a pericardiocentesis was performed.150 ml of blood were drawn from the pericardial space, and the patient's vitals returned to normal and became stable.The needle was disposed.
Additional Manufacturer Narrative
Correction to the as reported- impact code mdr in block(s) f10 and h6.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.
Event or Problem Description
It was reported that during a left atrial appendage (laa) closure procedure, a nrg needle was selected for use.Post transeptal puncture it was difficult to get a non-boston scientific sheath across the septum.Once the sheath was across, the staff prepped the watchman access sheath for exchange and during this time, left sided access was lost and transesophageal echocardiography (tee) imaging noticed a new pericardial effusion.The patient vitals started to decline, the procedure was cancelled and a pericardiocentesis was performed.150 ml of blood were drawn from the pericardial space, and the patient's vitals returned to normal and became stable.The needle was disposed.

• 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: 16809889
• Report Number: 2124215-2023-18191
• Device Sequence Number: 6105817
• Product Code: DXF
• UDI-Device Identifier: 00685447000259
• UDI-Public: 00685447000259
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 06/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2025
• Device Model Number: NRG-E-HF-98-C1
• Device Lot Number: NGFF041122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female