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

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/25/2023
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 during a watchman procedure, a bmc nrg transseptal needle was selected for use.The transseptal was attempted for 20 minutes, crossing once, system came back.Pericardial effusion was noted during pre transseptal.Then tried longer, it was noticed a pericardial effusion larger than prior.It was noted on transesophageal echocardiogram (tee) that a trace around the heart to start right side and appeared to be getting larger over time.Presumed cause was crossing too posterior or puncturing the right aortic arch (raa) with the non-boston scientific sheath.Pericardial effusion location was at right atrium and ventricle.There was a cardiac tamponade, patient was stable throughout, low blood pressure was noted.Physician is not sure if it was location of transseptal puncture or multiple maneuvers and re-wires to the superior vena cava (svc).Small effusion noted prior to procedure, size was not noted.After the procedure, the effusion was noticeably larger and got larger.There was difficulty getting transseptal, seeing tent on septum on imaging.Multiple attempts required to track up / drop down into position on septum before transseptal puncture was performed.Physician the performed a pericardial thoracentesis.Procedure was cancelled to stabilize the patient.Patient was sedated when the procedure was cancelled.Patient was not on warfarin at this point.Patient stopped xarelto prior to case.Patient is expected to fully recover and to be discharged the following day.
Additional Manufacturer Narrative
Additional information added to b5 event description and f10 patient and impact codes, h6 evaluation codes.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 during a watchman procedure, a bmc nrg transseptal needle was selected for use.The transseptal was attempted for 20 minutes, crossing once, system came back.Pericardial effusion was noted during pre transseptal.Then tried longer, it was noticed a pericardial effusion larger than prior.It was noted on transesophageal echocardiogram (tee) that a trace around the heart to start right side and appeared to be getting larger over time.Presumed cause was crossing too posterior or puncturing the right aortic arch (raa) with the non-boston scientific sheath.Pericardial effusion location was at right atrium and ventricle.There was a cardiac tamponade, patient was stable throughout, low blood pressure was noted.Physician is not sure if it was location of transseptal puncture or multiple maneuvers and re-wires to the superior vena cava (svc).Small effusion noted prior to procedure, size was not noted.After the procedure, the effusion was noticeably larger and got larger.There was difficulty getting transseptal, seeing tent on septum on imaging.Multiple attempts required to track up / drop down into position on septum before transseptal puncture was performed.Physician the performed a pericardial thoracentesis.Procedure was cancelled to stabilize the patient.Patient was sedated when the procedure was cancelled.Patient was not on warfarin at this point.Patient stopped xarelto prior to case.Patient is expected to fully recover and to be discharged the following day.It was further reported that during the procedure, the patient had his heart perforated in two different places.After this happened, he had to have open heart surgery to repair the two perforated places by a thoracic surgeon.During this time, he had his left atrial appendage closed manually.Patient had to be hospitalized and put in rehab for approximately one month and one day post procedure, is now at home and feeling well.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 17163331
• Report Number: 2124215-2023-30393
• Device Sequence Number: 5758043
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/01/2023

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: 09/27/2025
• Device Model Number: NRG-E-HF-71-C1
• Device Lot Number: NGFF140323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male