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	Bradycardia (1751)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A case of bradycardia requiring intervention was reported during a left atrial appendage closure (laac) procedure where the nrg transseptal needle (baylis medical company) was used with an sl1 sheath (st.Jude medical) for initial transseptal puncture.Transseptal access was initially attempted using the versacross transseptal sheath and versacross rf wire (baylis medical company).However, the devices could not be successfully positioned due to complex patient anatomy.The physician exchanged the versacross devices with a nrg transseptal needle and a sl1 sheath.The physician continued to experience difficulty positioning the sl1 sheath and the nrg transseptal needle.While the devices were being maneuvered, the sheath made contact with the av node resulting in bradycardia.The procedure was aborted and a temporary pacemaker was inserted into the patient.The patient was transferred to the icu for monitoring and recovery.The patient's heart rhythm returned to normal and the temporary pacemaker was later removed.There is no reasonable evidence to suggest that a baylis medical device caused or contributed to the reported incident.However, as baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.
Additional Manufacturer Narrative
There is no reasonable evidence to suggest that a baylis medical device caused or contributed to the reported incident.However, as baylis medical device was reported to be among the devices used in the procedure, baylis medical has decided to submit this report.A dhr review on all devices in the lot was completed and all devices met relevant specifications prior to release; device malfunction is not suspected.

• 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: 14504421
• Report Number: 9710452-2022-00047
• Device Sequence Number: 5106271
• Product Code: DXF
• UDI-Device Identifier: 00685447004530
• UDI-Public: (01)00685447004530(17)250202(10)NGFE310122
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 02/02/2025
• Device Model Number: NRG-E-HF-71-C1
• Device Lot Number: NGFE310122
• 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: 04/27/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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