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

Lot Number	NGFA300123
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has returned for analysis.Upon receipt at our post market quality assurance laboratory, the nrg rf needle was visually inspected and found to have its distal tip broken and detached.The ptfe was also not visible near the fracture area.Next, the device passed the flushing test (pre and post decontamination).The device failed curve overlay test as the distal tip was missing and the curve standards were not met.From vhx images, the fracture at the joint area was observed.Additionally, the device passed the proximal outer diameter testing, which was under specifications.However, it was not possible to measure the distal outer diameter, since this section was missing from the device.The allegation was confirmed based on the product returned analysis and inspection.Based on all the available information, the cause of the reported damage on the device was likely attributed to a failure to follow instructions, as there was evident the distal tip was broken and detached from the device, possibly due to manual reshaping of the tip of the needle or possible excessive force was applied to the rf needle during shipping, unpackaging, or peri-procedurally, leading to a high stress concentration at the shaft shoulder ultimately causing deformation.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
Reportable based on analysis completed on 19apr2025 it was reported an nrg transseptal needle was selected for use for an electrophysiology procedure to treat a case of atrial fibrillation (a fib).However, upon removal from the packaging it was noted that the needle had signs of damage/defectiveness and could therefore not be used.The procedure was initially halted and eventually completed successfully using a different device (same model).No patient complications reported.The product has returned for analysis.However, analysis revealed that the nrg needle tip was broken and fully detached.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22037063
• Report Number: 2124215-2025-31550
• Device Sequence Number: 18230381
• Product Code: DXF
• UDI-Device Identifier: 00685447000204
• UDI-Public: 00685447000204
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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 Expiration Date: 01/30/2026
• Device Lot Number: NGFA300123
• 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: 04/19/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown