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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/13/2025
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.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 at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported patient experienced pericardial affusion and cardiac tamponade.During a concomitant pulse field ablation (pfa) and watchman procedure, a nrg transseptal needle was selected for use.The patient had complicated anatomy due to kyphosis.The physician had difficulty performing transeptal puncture due to anatomy.Post transseptal, the patient maintained baseline hemodynamics.A non-boston scientific pfa catheter inserted, and ablation was performed.Upon removal of ablation catheter, imaging physician noticed a moderate sized effusion on transesophageal echocardiogram (tee).A watchman device deployed successfully.A pericardiocentesis was performed post successful implant.Later, the patient underwent surgery and was hospitalized and discharged on (b)(6) 2025.The device is not expected to be returned for analysis (disposed).The physician believes that maybe the event occurred while trying to gain transeptal access.
Event or Problem Description
It was reported patient experienced pericardial affusion and cardiac tamponade.During a concomitant pulse field ablation (pfa) and watchman procedure, a nrg transseptal needle was selected for use.The patient had complicated anatomy due to kyphosis.The physician had difficulty performing transeptal puncture due to anatomy.Post transseptal, the patient maintained baseline hemodynamics.A non-boston scientific pfa catheter inserted, and ablation was performed.Upon removal of ablation catheter, imaging physician noticed a moderate sized effusion on transesophageal echocardiogram (tee).A watchman device deployed successfully.A pericardiocentesis was performed post successful implant.Later, the patient underwent surgery and was hospitalized and discharged on (b)(6) 2025.The device is not expected to be returned for analysis (disposed).The physician believes that maybe the event occurred while trying to gain transeptal access.It was further confirmed that the patient had a median sternotomy performed by the physician along with a surgical repair of perforation at ivc-ra junction.
Additional Manufacturer Narrative
Due to additional information received, the initial mdr was updated for the fields describe event or problem (b5), in section b - adverse event/product prob and patient codes (f10 and h 6), in sections f - for use by uf/importer and h - device manufacturers only.Also, correction to the initial mdr in block(s) outcomes attrib to adv event (b2), 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 at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: 21753457
• Report Number: 2124215-2025-20344
• Device Sequence Number: 9658637
• Product Code: DXF
• UDI-Device Identifier: 00685447004523
• UDI-Public: (01)00685447004523
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/12/2025

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?: Yes
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White