MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

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

Patient Problems Non specific EKG/ECG Changes (1817); Ischemia (1942); Myocardial Infarction (1969)

Event Date 02/19/2024

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 st elevations, myocardial infarction / ischemia occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The physician performed transseptal puncture (tsp) and about two minutes, st elevations were present for a rapid period of time and patient went back to sinus rhythm.An interventional cardiology (ic) physician was consulted and gave contrast shot in coronary arteries.It was noted that the patient had a chronic disease, blockage in the right coronary arteries.The ic physician put a stent in the patient.The watchman procedure was cancelled.The patient was expected to be stable with no more complications.The device is not expected to be returned for analysis.Both physicians believed that the tsp procedure did not contribute the event.The patient was hospitalized beyond standard of care.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• 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: 18926312
• MDR Text Key: 337927527
• Report Number: 2124215-2024-15498
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White