MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC NRG TRANSSEPTAL NEEDLE; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-71-C1
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon 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 nrg transseptal needle was selected for pulmonary vein isolation.During transseptal puncture, the physician was able to cross the septum with the nrg needle, but it was reported that the nrg needle did not respond as normal, and it seemed that the radio frequency (rf) was not delivered.No error code was reported.The device was reconnected still the issue persisted.Extra force was needed to cross the septum.The procedure was completed successfully.No patient complication was reported.The needle has returned for analysis and the investigation is still in progress.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the nrg needle passed flow test, as it flushed properly (pre-decontamination).The device passed visual test, as the active tip length was confirmed to be within specifications.The eprom read testing confirmed that the needle was successfully connected to the generator.Also, the curve was within specifications per the curve overlay, hence the reach of the device was within specifications.Furthermore, no charring on tip and no wear on the distal edge of the heat shrink were noted, along with no relaxation of the curve, indicating device was likely not assembled into a dilator and radio frequency was never delivered.Therefore, the reported allegation is not confirmed based on the inspection results of the returned product.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that nrg transseptal needle was selected for pulmonary vein isolation.During transseptal puncture, the physician was able to cross the septum with the nrg needle, but it was reported that the nrg needle did not respond as normal, and it seemed that the radio frequency (rf) was not delivered.No error code was reported.The device was reconnected still the issue persisted.Extra force was needed to cross the septum.The procedure was completed successfully.No patient complication was reported.The needle has 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: 21632507
• Report Number: 2124215-2025-16653
• Device Sequence Number: 9246143
• Product Code: DXF
• UDI-Device Identifier: 00685447004530
• UDI-Public: 00685447004530
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/19/2025

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-C1
• Device Catalogue Number: NRG-E-HF-71-C1
• Device Lot Number: 0035128936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown