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

Lot Number NGFD161023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 02/14/2024

Event Type  Injury  

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 Description

It was reported a cardiac tamponade occurred.The procedure was cancelled.During a cryoablation procedure to treat atrial fibrillation (a fib), a nrg transseptal needle was selected for use.The patient anatomy had the inferior vena cava connected to the right atrium from the right side than usual.The transseptal puncture was performed without any issues.It was noted that the patient blood pressure decreased and cardiac tamponade was diagnosed.Pericardial drainage was performed, and the procedure was cancelled.The device is not expected to be returned for analysis.It was further confirmed that there was difficult patient anatomy where the inferior vena cava was connected to the right atrium from the right side than usual.There was no issues noted during the transseptal puncture.No imaging issues noted.Cardiac tamponade occurred just after transseptal puncture before sheath enters left atrium and conducts ablation.There were no reasons to believe nrg needle malfunctioning or causing patient complication.

• Brand Name: RF NEEDLE
• Type of Device: 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: 18874757
• MDR Text Key: 337321513
• Report Number: 2124215-2024-13527
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: NGFD161023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention