MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Heart Block (4444)

Event Date 12/07/2023

Event Type  Injury  

Event Description

It was reported that st elevation and heart block occurred.During the watchman procedure to treat fall risk, a versacross connect kit was selected for use.The transseptal puncture was performed successfully.The versacross radio frequency wire was placed in the left upper pulmonary vein (lupv) and the versacross dilator was removed.Following the removal of the versacross dilator, st elevation was noted and 2:1 heart block occurred.Medication was administered and a temporary pacemaker was placed.A coronary angiogram identified diminished right ventricle function with no evidence of an air embolism.About ten minutes after, the patient stabilized and cardiac function was restored.The closure device was successfully implanted, and the procedure completed.During recovery, the patient passed all neurological examinations.The physician believes there might have been air suctioned into the watchman sheath as the versacross dilator was removed due to the lack of tight hemostatic valve on the sheath.No further patient complications were reported.The patient fully recovered and was discharged one day post index procedure.The device is not expected to be returned for analysis.Pn-1977810.

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: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 18356356
• MDR Text Key: 330888922
• Report Number: 2124215-2023-72100
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/19/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male