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

Model Number	NRG-E-HF-98-C1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nrg transeptal needle/baylis needle was placed into agilis steerable sheath.The physician verbalized that upon advancing the baylis into the agilis that he was met with an abnormal amount of resistance.When the needle was removed, the needle was bent/had a visual abnormality.A second agilis and baylis needle was obtained, and the same scenario occurred.The needle did not enter the patient's body.The sheath entered the patient¿s body.There was no harm to the patient.There were a total of two agilis uses and two baylis needles.Nrg transeptal needle baylis large curve lot #: ngfd310323.

• Brand Name: NRG TRANSSEPTAL NEEDLE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY, INC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 18282061
• Report Number: 18282061
• Device Sequence Number: 6846992
• Product Code: DXF
• UDI-Device Identifier: 00685447000259
• UDI-Public: (01)00685447000259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/29/2023
• Report Date (Section F): 11/29/2023

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 Model Number: NRG-E-HF-98-C1
• Device Lot Number: NGFD010523
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2023
• 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: Male
• Patient Weight: 105 KG
• Patient Race: White
• Date Report Sent to FDA: 11/29/2023