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

Model Number	NRG-E-HF-71-C0
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle was returned in its tray, pouch, and shelf box, all of which was enclosed in a plastic bag.The needles shaft was kinked due to visible manual reshaping.In addition, the distal tip of the needle was broken at the distal joint area.There were no obvious defects with the handle or the connector.The distal side-ports appeared to be clear of debris.The distal tip of the needle was broken at the distal to proximal hypotube joint.This is probably due to manual reshaping of the needle which is evident along the curve profile.The side-ports appear to be free of defects.Needle curve compared to nrg c0 overlay and did not pass, the needle shaft was bent due to manual reshaping of the needle along the curve profile and the distal tip at the distal to proximal hypotube joint was broken.Proximal od and proximal hypotube od were within specifications.The reported event was confirmed.
Event or Problem Description
Reportable based on analysis completed on 09jun2023.It was reported that a nrg transseptal needle was selected for use.During a transeptal puncture to treat an atrium fibrillation, the nrg needle was noted to be bent at the tip, when it was reinserted into the dilator.A new device was inserted, and septal puncture was performed without any problem.Also, on fluoroscopy, the tip from the dilator looked different than usual, so it was pulled out once, and confirmed that the tip was bent.No patient complications were reported.The procedure was completed successfully.However, analysis of the returned device revealed that the tip of the needle was broken and detached.

• 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 ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17226662
• Report Number: 2124215-2023-33610
• Device Sequence Number: 17916761
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2023

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: 11/07/2024
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFB251121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown