MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. BAYLIS RFP-100A REPAIR KIT; CATHETER, SEPTOSTOMY

Model Number	NRG-E-HF-71-C0
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device was discarded at the health care facility and will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
During transseptal puncture a nrg transseptal needle was selected for use.After opening the device as usual, flushing was performed and the device was inserted into the sheath.It was reported that although energization was done, the tip did not pass through the interatrial septum, insertion was repeated about three times, but it was still unable to cross.The needle was removed and the tip was checked, which revealed that some parts of polytetrafluoroethylene coating up to about three centimeters from the tip were peeled off.A new needle was used and crossing was completed successfully with one energization with no patient complications.

• Brand Name: BAYLIS RFP-100A REPAIR KIT
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal qc 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: 16663526
• Report Number: 2124215-2023-11410
• Device Sequence Number: 12279966
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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: 01/19/2025
• Device Model Number: NRG-E-HF-71-C0
• Device Lot Number: NGFA180122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown