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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Codes	Use of Device Problem (1670); Obstruction of Flow (2423); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
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 during a procedure a nrg transseptal needle was selected for use.During the procedure the rf needle was flushed with saline solution and more resistance than usual was felt, however, the procedure continued, and the needle was inserted into the right atrium and energization was performed but septal puncture could not be achieved.The rf needle was removed from the sheath and flushed with saline solution again, but it could not be flushed.A new rf needle was used and septal puncture was performed.The procedure was completed successfully without any patient complications.The device is expected to be returned for laboratory analysis.
Event or Problem Description
It was reported that during a procedure a nrg transseptal needle was selected for use.During the procedure the rf needle was flushed with saline solution and more resistance than usual was felt, however, the procedure continued, and the needle was inserted into the right atrium and energization was performed but septal puncture could not be achieved.The rf needle was removed from the sheath and flushed with saline solution again, but it could not be flushed.A new rf needle was used and septal puncture was performed.The procedure was completed successfully without any patient complications.The device is expected to be returned for laboratory analysis.
Additional Manufacturer Narrative
Correction to d1: brand name from baylis rfp-100a repair kit to nrg transseptal needle.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 during a procedure a nrg transseptal needle was selected for use.During the procedure the rf needle was flushed with saline solution and more resistance than usual was felt, however, the procedure continued and the needle was inserted into the right atrium and energization was performed but septal puncture could not be achieved.The rf needle was removed from the sheath and flushed with saline solution again, but it could not be flushed.A new rf needle was used and septal puncture was performed.The procedure was completed successfully without any patient complications.The device has been returned for investigation.
Additional Manufacturer Narrative
Correction to f10 & h6 - component codes and evaluation result codes.The needle was returned in its tray & pouch.All enclosed in a transparent plastic bag.There were no visual defects on the proximal shaft or the distal shaft.Moreover, there were no obvious defects with the handle or the connector.The distal sideports and the luer at the handle appeared to be clear of debris and free of defects.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, 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 our 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 during a procedure a nrg transseptal needle was selected for use.During the procedure the rf needle was flushed with saline solution and more resistance than usual was felt, however, the procedure continued and the needle was inserted into the right atrium and energization was performed but septal puncture could not be achieved.The rf needle was removed from the sheath and flushed with saline solution again, but it could not be flushed.A new rf needle was used and septal puncture was performed.The procedure was completed successfully without any patient complications.The device has been returned for investigation.
Additional Manufacturer Narrative
The needle was returned in its tray & pouch.All enclosed in a transparent plastic bag.There were no visual defects on the proximal shaft or the distal shaft.Moreover, there were no obvious defects with the handle or the connector.The distal sideports and the luer at the handle appeared to be clear of debris and free of defects.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, 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 our 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.

• 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 degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16628619
• Report Number: 2124215-2023-13009
• Device Sequence Number: 4458213
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2023

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: 09/15/2024
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFA140921
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 05/02/2023; 05/25/2023; 06/22/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/20/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown