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

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nrg rf needle was selected for use during an unknown procedure.During the transseptal puncture, the footswitch was stepped on, however the nrg needle did not energize.Another re-sterilized cable was used (replaced), but the situation did not change; therefore, the rf needle was replaced and the procedure was performed.It is not a reprocessed needle.No issue was noted with the footswitch.No alert/error was displayed when rf was attempted.At this time, it has been heard a "beep" sound twice once trying to deliver rf.The procedure and indication was a transseptal.No patient complications were reported and the procedure was completed successfully.
Additional Manufacturer Narrative
The device has returned for evaluation and it's investigation was completed on 13jul2023.The device passed the design specifications for the active tip length measurement, continuity test, as well as the puncture test performed on a top-bench model.Moreover, the distal sideports of the needle as well as the luer at the handle appeared to be clear of debris and free of defects.The device, however, failed the design specification for the curve overlay inspection, which was due to the manual reshaping of the needle that was evident along the curve profile.It is highly unlikely that the rf needle left facility like that since all needles undergo 100% visual verification for the distal curve shape prior to packaging.Moreover, the device's ifu clearly states that manual reshaping and/or bending of the needle is not recommended because it could damage the integrity of the needle and cause injury to the patient.
Event or Problem Description
It was reported that a nrg rf needle was selected for use during an unknown procedure.During the transseptal puncture, the footswitch was stepped on, however the nrg needle did not energize.Another re-sterilized cable was used (replaced), but the situation did not change; therefore, the rf needle was replaced and the procedure was performed.It is not a reprocessed needle.No issue was noted with the footswitch.No alert/error was displayed when rf was attempted.At this time, it has been heard a "beep" sound twice once trying to deliver rf.The procedure and indication was a transseptal.No patient complications were reported and the procedure was completed successfully.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17100348
• Report Number: 2124215-2023-24824
• Device Sequence Number: 1907675
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2025
• Device Model Number: NRG-E-HF-71-C1
• Device Lot Number: NGFH060422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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: Other
• Patient Sex: Unknown