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 Problem Perforation of Vessels (2135)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure.A perforation was noted after initial and only transeptal puncture.The physician initiated a transseptal along with the versacross connect system.The device was tenting on the anterior portion of the fossa.Radio frequency was applied.During the 2 second pulse, the tip of the versacross rf wire was advanced across the fossa and curled into the aorta.Bubbles we're identified in the aorta by the echo physician and notified the physician.The versacross rf wire way retracted and flow from the aorta to the left atrium - la was visualized with color doppler.Cardiac surgery was consulted, and it was decided to continue with the warthman implant.Thus, a new transseptal was done.After the watchman was released, the color doppler was not visual showing flow from the aorta to the la.The first and only cross was through the fossa (inferior and anterior), once the versacross rf wire was advanced and perforated the aorta.No other adverse event was noted.The procedure was completed successfully.The patient had fully recovered.No other issues were noted.There were no device related issues noticed.There was no clinical intervention as a result of the aortic perforation at the time of the procedure.There is no reason to believe that the versacross wire malfunctioned during the procedure.The device is not expected to be returned for analysis (disposed).

Event Description

It was reported that a versacross connect access solution was selected for use during a watchman procedure.A perforation was noted after initial and only transspetal puncture.The physician initiated a transseptal along with the versacross connect system.The device was tenting on the anterior portion of the fossa.Radio frequency was applied.During the 2 second pulse, the tip of the versacross rf wire was advanced across the fossa and curled into the aorta.Bubbles we're identified in the aorta by the echo physician and notified the physician.The versacross rf wire way retracted and flow from the aorta to the left atrium - la was visualized with color doppler.Cardiac surgery was consulted, and it was decided to continue with the warthman implant.Thus, a new transseptal was done.After the watchman was released, the color doppler was not visual showing flow from the aorta to the la.The first and only cross was through the fossa (inferior and anterior), once the versacross rf wire was advanced and perforated the aorta.No other adverse event was noted.The procedure was completed successfully.The patient had fully recovered.No other issues were noted.There were no device related issues noticed.There was no clinical intervention as a result of the aortic perforation at the time of the procedure.There is no reason to believe that the versacross wire malfunctioned during the procedure.The device is not expected to be returned for analysis (disposed).On 13oct2023, it was further confirmed that the unp for the product used in this case was vxak0007 (not vxak0005).

• 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: 17883038
• MDR Text Key: 325061188
• Report Number: 2124215-2023-54074
• 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,Followup
• Report Date: 11/06/2023

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: 09/07/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 11/06/2023
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male