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

Lot Number	NGFA061023
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
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 use for an unknown procedure.It was mentioned that the needle was broken/snapped before using or touching it.Procedure outcome was not provided.No patient complications were reported.Product is not expected to return for analysis.(b)(4).
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the needle was visually inspected.This inspect confirmed that the tip of the needle was broken.Based on all available information the cause of the damage could not be established as the needle passed visual inspection prior to packaging but the event description says the needle was broken prior to being touched by hospital staff.
Event or Problem Description
It has been reported that an nrg transseptal needle was selected for use for an unknown procedure.It was mentioned that the needle was broken/snapped before using or touching it.Procedure outcome is currently unknown.No patient complications reported.The needle has been received by boston scientific for analysis.

• 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: 19164335
• Report Number: 2124215-2024-24526
• Device Sequence Number: 7382251
• Product Code: DXF
• UDI-Device Identifier: 00685447000211
• UDI-Public: 00685447000211
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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
• Device Lot Number: NGFA061023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown