MAUDE Adverse Event Report: BAYLIS MEDICALE CIE 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	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an atrial fibrillation procedure, a nrg transseptal needle was selected for use.When the physician went to apply radio frequency (rf) via nrg on the septum to go transseptal, the rf was appearing to have delivered but access to the left atrium (la) was not gained.The tip of the nrg needle was confirmed to be extended past the sheath.The one second constant parameter was used on the generator and there were no errors when the rf button was pressed.The physician tried repositioning and redelivering rf a few more times but issue persisted.Thus, the physician requested a new nrg needle.With the new nrg needle, rf was delivered with the same parameters, and gained access into the la on the first try.The procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
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.
Additional Manufacturer Narrative
The device was returned for analysis.Upon receipt at our post market quality assurance laboratory, the nrg needle failed the visual inspection, as there were signs of manual reshaping at the distal end and shaft of the needle.The device passed flow test, since it was able to flush properly without any leakage through the luer port.Next, the device met the device specification which includes distal hypotube outer diameter.The nrg needle failed the functional test for curve overlay, which concludes that the needle was manually reshaped.Finally, the needle passed the functional tissue test, as successfully delivered rf energy and crossed tissue on bench top test.The information provided in the complaint indicates potential manual reshaping occurred and labeling review was conducted.It was determined there was evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use, which warns the user to 'do not bend the nrg transseptal needle.Excessive bending or kinking of the needle tip may damage the integrity of the needle and may cause patient injury.Care must be taken when handling the needle'.The allegation of failure to cross septum cannot be confirmed as issue was not replicated on the bench top test.
Event or Problem Description
It was reported during an atrial fibrillation procedure, a nrg transseptal needle was selected for use.When the physician went to apply radio frequency (rf) via nrg on the septum to go transseptal, the rf was appearing to have delivered but access to the left atrium (la) was not gained.The tip of the nrg needle was confirmed to be extended past the sheath.The one second constant parameter was used on the generator and there were no errors when the rf button was pressed.The physician tried repositioning and redelivering rf a few more times but issue persisted.Thus, the physician requested a new nrg needle.With the new nrg needle, rf was delivered with the same parameters, and gained access into the la on the first try.The procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.The device was returned for analysis.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21105114
• Report Number: 2124215-2024-83088
• Device Sequence Number: 18148409
• Product Code: DXF
• UDI-Device Identifier: 00685447004523
• UDI-Public: 00685447004523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Model Number: NRG-E-HF-71-C0
• Device Catalogue Number: NRG-E-HF-71-C0
• Device Lot Number: 0034372820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown