MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. NRG TRANSSEPTAL NEEDLE; RF TRANSSEPTAL NEEDLE

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemothorax (1896)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a ventricular tachycardia ablation in a patient with paraplégia, a hemothorax occurred.There was no possibility to use femoral access and retro aortic access was not an option either due to an aortic mechanical valve.Therefore, the physician decided to use the jugular venous approach and transseptal to access the left ventricle (lv).The first intent was to perform a ventricular transseptal but the physician was not able to pass through the tricuspid valve.The second attempt was to perform an atrial transseptal, using agilis epi and baylis needle, but stability was poor.Transesophageal echocardiography was used in both cases.The physician then decided to perform a trans-apical puncture, directly through the lv apex.Agilis epi was inserted into the lv and an hd grid and then the tacticath catheter was used to map the lv and ventricular tachycardia.The patient was stable throughout the entire case.Mapping and ablation could be performed without any hemodynamical issue.The physician decided to remove the catheters and closed the puncture using a femoseal device; no blood leakage was observed.Shortly after, saturation lowered and analysis confirmed a hemothorax, with blood compressing the lungs and the patient was sent to surgery.The blood was drained and it was confirmed that no leakage was observed from the lv.The patient was stable after the surgery.There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.Baylis medical has decided to submit this report because the nrg transseptal needle was reported to be among the devices used in the procedure.
Additional Manufacturer Narrative
There is no evidence to suggest that the baylis medical device caused or contributed to the reported incident.However, as a baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.There is no suspected device failure.Dhr review was completed and the device fulfilled all requirements prior to release.Baylis medical's nrg transseptal needle is indicated for creating an atrial septal defect and as per the labeling, it is intended to be used from femoral access and not transapical access.The device used for transapical access in the procedure is not known.Further information will be requested from the site to get further understanding of the procedure workflow and contributory causes.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: RF TRANSSEPTAL NEEDLE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2775 matheson blvd. east; mississauga, ontario L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: meghal khakhar ; 2775 matheson blvd. east; mississauga, ontario L4W 4-P7 ; CA L4W 4P7
• MDR Report Key: 13286056
• Report Number: 9710452-2022-00008
• Device Sequence Number: 4405665
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: (01)00685447000211(17)240616(10)NGFA160621
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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: 06/16/2024
• Device Model Number: NRG-E-HF-71-C1
• Device Lot Number: NGFA160621
• 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: 12/21/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown