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

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported a pericardial effusion was occurred.During a procedure, which a non-boston scientific soundstar map was made and a coronary sinus map using the non-boston scientific catheter.An unknown boston scientific transseptal puncture needle was selected for use.A non-boston scientific mapping catheter and transseptal puncture needle and non-boston scientific wire were used and the transseptal puncture was performed.The needle was inserted in the left atrium prior to sheath or catheter going transseptal.When the needle was being replaced by a non-boston scientific sheath, a pericardial effusion was noted.The transseptal wire was removed and protamine was given.The patient became hypotensive.A pericardiocentesis was performed and 800cc of fluid was withdrawn.The patient was stabilized and fully recovered.The device is not expected to be returned for analysis.Later, it was reported that no transseptal puncture was performed and the adverse event was discovered after the boston scientific needle was inserted into the left atrium prior to the non-boston scientific sheath going transseptal.No catheter or sheath crossed the septum.No oblation catheters were inserted into the body of the patient.The patient has fully recovered.Medwatch report# mw5150931.

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.

• Brand Name: NRG RF TRANSSEPTAL KIT
• 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: 18914284
• MDR Text Key: 337785370
• Report Number: 2124215-2024-15758
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention