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

Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It has been reported that an nrg transseptal needle was selected for atrial fibrillation (a fib) ablation.During the procedure, the nrg needle was advanced 2 cm from the tip of dilator.When retracting sheath and dilator together to expose nrg needle, its tip would not move past the tip of the dilator.Thus, when the nrg needle was removed from the dilator, it was noted to have its tip damaged, its distal end was strip off.The needle was then replaced, non-boston scientific needle was used, and the procedure was completed successfully.No patient complications were reported.The device is not returning as discarded in facility.No other issues were noted.
Additional Manufacturer Narrative
The nrg needle was not returned for analysis.However, based on the media provided, the reported allegation for coating issue was confirmed.Thus, a supplemental mdr is being filed.
Event or Problem Description
It has been reported that an nrg transseptal needle was selected for atrial fibrillation (a fib) ablation.During the procedure, the nrg needle was advanced 2 cm from the tip of dilator.When retracting sheath and dilator together to expose nrg needle, its tip would not move past the tip of the dilator.Thus, when the nrg needle was removed from the dilator, it was noted to have its tip damaged, its distal end was strip off.The needle was then replaced, non-boston scientific needle was used, and the procedure was completed successfully.No patient complications were reported.The device is not returning as discarded in facility.No other issues were noted.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20240706
• Report Number: 2124215-2024-58122
• Device Sequence Number: 8043260
• Product Code: DXF
• UDI-Device Identifier: 00685447000198
• UDI-Public: 00685447000198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/28/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown