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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the needle failed to cross the septum and had a kink in the tip.During a procedure an nrg transseptal needle was selected for use.A first puncture was successful, but the sheath came out due to an operation error.Energization was performed twice attempting to puncture again, but the needle did not cross.During energization an energization sound was heard, but no error message appeared.When the needle was removed from the sheath a kink in the tip was confirmed.The needle was replaced with another of the same model and the procedure was completed.No patient complications were reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Correction to the initial mdr in block g2 report source (other) from blank to japan.The nrg transseptal needle was returned to boston scientific for analysis.Upon receipt at our post market quality assurance laboratory the needle underwent an active tip length measurement, inspection of joint and sideports, inspection with curve overlay, proximal and distal outer diameter inspections, a continuity test, and a puncture test.The needle passed the active tip length measurement as it was found to be within specification.Vhx inspections of the distal to proximal hypotube joint showed a bending in the joint which could be due to the kinking that resulted due to an operation error during the procedure.The sideports appear to be free of defects.The inspection with curve overlay found the needle tip was bent due to manual reshaping of the needle along the curve profile.Found the proximal and distal outer diameter inspections found were passed since the device was within specification.The device passed the continuity test, and also passed the puncture test by successfully delivering radio frequency energy.The reported clinical observation of difficult to cross septum was not confirmed by the analysis.However, the kink in the distal tip was confirmed.
Event or Problem Description
It was reported that the needle failed to cross the septum and had a kink in the tip.During a procedure an nrg transseptal needle was selected for use.A first puncture was successful, but the sheath came out due to an operation error.Energization was performed twice attempting to puncture again, but the needle did not cross.During energization an energization sound was heard, but no error message appeared.When the needle was removed from the sheath a kink in the tip was confirmed.The needle was replaced with another of the same model and the procedure was completed.No patient complications were reported.The device is expected to be returned for analysis.

• 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: 16947153
• Report Number: 2124215-2023-19599
• Device Sequence Number: 2252228
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 11/07/2024
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFB251121
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male