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

Lot Number NGFC061023

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 02/02/2024

Event Type  Death  

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 that a nrg transseptal needle was selected for use.A cardiac tamponade was reported.The patient has passed away.During a cryo procedure, a cardiac tamponade occurred, and a pericardiocentesis was performed.After the pericardiocentesis, the patient's condition temporarily stabilized, but it appears that the condition did not change suddenly afterwards.It is unknown whether the thoracotomy was held.The patient died next day.It was reported that the contributor factor to the complication was that while trying to place a non-boston scientific medtronic's achieve in ripv (right inferior pulmonary vein), it penetrated it.An autopsy was performed, and the official cause of death was 2 (two) holes at ripv.No pericardial effusion (pe) was noted on echo before the procedure.No other difficulties or complications were noted during the procedure.No physical damage was observed in the nrg rf needle prior to the procedure.The patient did not suffer from any health issue prior to the procedure that could have led to the adverse event.No malfunction was reported with the nrg needle.There was no allegation of contribution from the nrg rf needle to the complications reported.The procedure was cancelled.The device is not expected to be returned for analysis (discarded).

• 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: 18828255
• MDR Text Key: 336802365
• Report Number: 2124215-2024-08987
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: NGFC061023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death