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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/21/2025
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.Good faith effort attempts are in progress to try and retrieve additional details regarding the reported event, but further information was unable to be obtained as of yet.
Event or Problem Description
A thrombus was noted and the procedure was cancelled.It has been reported that an nrg transseptal needle was selected for use for a watchman left atrial appendage closure (laac).During the procedure, the physician mentioned that they saw what appeared to be some heavy slush in the left atrial appendage when transesophageal echocardiography (tee) was performed.They decided to proceed with their transseptal workflow using the nrg needle and an sl0 sheath.As soon as transseptal access was achieved and they got access to the left atrium (la), the slush that was noted earlier became a clot, and the physicians decided to abort the procedure.There were no changes in the patients vitals, the patient remained stable through the entire procedure.Product is not expected to return for analysis (disposed).
Event or Problem Description
A thrombus was noted and the procedure was cancelled.It has been reported that an nrg transseptal needle was selected for use for a watchman left atrial appendage closure (laac).During the procedure, the physician mentioned that they saw what appeared to be some heavy slush in the left atrial appendage when transesophageal echocardiography (tee) was performed.They decided to proceed with their transseptal workflow using the nrg needle and an sl0 sheath.As soon as transseptal access was achieved and they got access to the left atrium (la), the slush that was noted earlier became a clot, and the physicians decided to abort the procedure.There were no changes in the patient's vitals, the patient remained stable through the entire procedure.Product is not expected to return for analysis (disposed).It has been further mentioned that no clot was seen on any of the products.The physician does not believe that the nrg needle contributed to the clot.The thrombus seen on the left side of the heart.No action taken to address the thrombus due to act being high.No further information about the patient was disclosed.
Additional Manufacturer Narrative
Due to additional information received, this supplemental mdr is being submitted for the updated field describe event or problem (b5), in section b - adverse event/product prob.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21599238
• Report Number: 2124215-2025-15607
• Device Sequence Number: 8938845
• Product Code: DXF
• UDI-Device Identifier: 00685447004523
• UDI-Public: (01)00685447004523
• 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,Followup
• Report Date (Section B): 06/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: NRG-E-HF-71-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female