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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device was discarded at the health care facility and will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
During transseptal puncture a nrg transseptal needle was selected for use.It was reported that an attempt was made to pass the needle through a non-boston scientific sheath to perform brockenbrough "bb" method puncture, but it was not able to cross; therefore, a new needle was used and crossing was completed successfully with no patient complications.The device was disposed following the procedure.
Additional Manufacturer Narrative
Correction to d1: brand name: updated from baylis rfp-100a repair kit to nrg transseptal needle.
Event or Problem Description
During transseptal puncture a nrg transseptal needle was selected for use.It was reported that an attempt was made to pass the needle through a non-boston scientific sheath to perform brockenbrough "bb" method puncture, but it was not able to cross; therefore, a new needle was used and crossing was completed successfully with no patient complications.The device was disposed following the procedure.It was further reported that two to three attempts to cross were made, however, it was unknown why the needle was unable to cross.The patient did not have tortuous or unusual anatomy.
Additional Manufacturer Narrative
The nrg transseptal needle was returned to boston scientific for analysis.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.The device, however, failed the design specification for the curve overlay inspection.The reported event could not be replicated during investigation because the returned needle was able to successfully deliver rf and puncture tissue when tested on a benchtop model.It is possible that it was challenging for the physician to achieve acceptable contact between the active electrode of the needle and the tissue, leading to failure to cross the septum.It is also possible that there was improper timing between advancement of the rf needle and the delivery of rf, which can also lead to failure to cross the septum.Moreover, the nrg needle could have been inside the sheath/dilator when attempting to deliver rf, which could have shielded the nrg tip and prevented rf delivery to the target anatomy.This could be the case due to the evident manual reshaping of the needle along the curve profile, where the curvature of the needle could have prevented its proper advancement through the sheath/dilator.
Event or Problem Description
During transseptal puncture a nrg transseptal needle was selected for use.It was reported that an attempt was made to pass the needle through a non-boston scientific sheath to perform brockenbrough "bb" method puncture, but it was not able to cross; therefore, a new needle was used and crossing was completed successfully with no patient complications.The device was disposed following the procedure.It was further reported that two to three attempts to cross were made, however, it was unknown why the needle was unable to cross.The patient did not have tortuous or unusual anatomy.

• 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 L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16558100
• Report Number: 2124215-2023-11414
• Device Sequence Number: 14808424
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: 00685447000204
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2023

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: 03/01/2025
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFA170222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 05/19/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown